Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Domestic: Duke University   Durham, NC  27708  Contact:  Francis Sun  Tel  919-684-2341      Foreign: None
Mod LabDiet 5058 w/150 ppm Fenbendazole  Plastic sealed bag in a box; 1 - 480 kg package
A manufacturing error resulting in Ivermectin used in place of Fenbendazole in custom research diet for mice resulted in mice mortality.
Product Code:  57T7; Manufactured 01/26/2015
goat pellets (16.5 lbs rumensin per ton) packaged into 50 lb. bags.  Manufactured by Frontier Cooperative Columbus, NE
Product contained elevated levels of monensin which resulted in animal death.
237.15.1 manufactured on or about 8/27/2015
Bulk Start 300 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac.  The responsible firm is Kassik Milling, Milligan, NE.
Bulk Prestart 550 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac.  The responsible firm is Kassik Milling, Milligan, NE.
Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey,  Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Shuttle Select Slip-Cath Catheter. Angiographic catheter.     For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over  an appropriately sized wire guide.
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters.
All lot numbers of the following  Product numbers:   SCBR4.5-35-135-P-NS-ANG-SHTL,  SCBR4.5-35-135-P-NS-ANG-SHTL-JP,  SCBR4.5-35-150-P-NS-0-SHTL,  SCBR4.5-35-150-P-NS-ANG-SHTL,  SCBR4.5-35-75-P-NS-ANGSHTL
US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
Their own retail store and 3 restaurants in Oregon
Label is black ink on an off white label.    No UPC
This voluntary recall was initiated after the manufacturing firm notified the recalling firm that products were possibly under- processed. Under-processed seafood could lead to contamination with Clostridium botulinum.
FROZEN KINGFISH STEAK, QF, IVP, Size: 10/12 OZ, WEIGHT 22 LBS, IMPORTER:PRESIDENT EAST COMPANY, PRODUCT OF TAIWAN, individual pieces are held within clear plastic vacuum-sealed packaging.
Recent FDA analysis determined that the product is decomposed and was also identified as Spanish mackerel.
PRODUCTION DATE: 2015/05/19  BEST BEFORE DATE: 2017/05/19
Philips Electronics North  America Corporation
Worldwide Distribution-US (nationwide) and the countries of  Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
Philips Healthcare IntelliVue Info Center iX, B.0,  866389   Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Philips Healthcare PIIC Classic Upgrade, 866117   Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g).  Packaged in a paper tray inside a plastic bag and wrapped around with paper band.   Made in Italy.  UPC 11150-50750
Roundy's is recalling Simply Roundy's Natural Authentic Italian Sweet Butternut Squash Ravioli because the product may contain undeclared cashew and almond.  This product was manufactured and recalled by Bertagni 1882 SpA of Arcugnano, Italy due to undeclared cashews and almonds.
Worldwide Distribution - US all states including PR except ND & RI.  International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
9131-001 Defibrillation Electrodes, Lot No. 141125-02  Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs  Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Defibrillation electrodes may exhibit higher than expected electrical impedance over time. If electrode impedance becomes too high, your Powerheart G3 Automatic External Defibrillator (AED) will fail the electrode self-test and it will not be Rescue Ready. If the AED fails the self-test, the STATUS INDICATOR on the AED will be RED and the AED will beep. This is normal and correct behavior when the
Nationwide Distribution  including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
Well at Walgreens***WARM   Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies
Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz.  The UPC is UPC 92438 00300
Great Pacific Bagel & Cream Cheese was recalled due to undeclared wheat
Worldwide Distribution - US Nationwide including Puerto Rico; Internationally:  Australia, Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritus, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, United Arab Emirates & United Kingdom
The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer
Serial Number range: 1801405 through 1918761
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549410  (XMD P/N 70-0050-B22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548230  (XMD P/N 70-0050-212)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548330  (XMD P/N 70-0050-014)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548700  (XMD P/N 70-0050-518)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548370  (XMD P/N 70-0050-414)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548870  (XMD P/N 70-0050-620)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548350  (XMD P/N 70-0050-214)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549340  (XMD P/N 70-0050-422)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549330  (XMD P/N 70-0050-322)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549590  (XMD P/N 70-0050-F24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M005489490  (XMD P/N 70-0050-524)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number  M00548430  (XMD P/N 70-0050-A14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549480  (XMD P/N 70-0050-424)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549360  (XMD P/N 70-0050-622)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549390  (XMD P/N 70-0050-922)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548280  (XMD P/N 70-0050-712)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548390  (XMD P/N 70-0050-614)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548500  (XMD P/N 70-0050-116)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548920  (XMD P/N 70-0050-B20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549370  (XMD P/N 70-0050-722)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548340  (XMD P/N 70-0050-114)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548760  (XMD P/N 70-0050-B18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549500  (XMD P/N 70-0050-624)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548380  (XMD P/N 70-0050-514)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548910  (XMD P/N 70-0050-A20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548900  (XMD P/N 70-0050-920)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549440  (XMD P/N 70-0050-E22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548950  (XMD P/N 70-0050-E20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548460  (XMD P/N 70-0050-D14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548800  (XMD P/N 70-0050-F18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548650  (XMD P/N 70-0050-G16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549510  (XMD P/N 70-0050-724)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548840  (XMD P/N 70-0050-320)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548970  (XMD P/N 70-0050-G20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548520  (XMD P/N 70-0050-316)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548490  (XMD P/N 70-0050-G14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548530  (XMD P/N 70-0050-416)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548750  (XMD P/N 70-0050-A18)
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548580  (XMD P/N 70-0050-916)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548720  (XMD P/N 70-0050-718)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548360  (XMD P/N 70-0050-314)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548250  (XMD P/N 70-0050-412)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  MM00548410  (XMD P/N 70-0050-814)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548470  (XMD P/N 70-0050-E14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549470  (XMD P/N 70-0050-324)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549530  (XMD P/N 70-0050-924)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548880  (XMD P/N 70-0050-720)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548850  (XMD P/N 70-0050-420)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548640  (XMD P/N 70-0050-F16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549550  (XMD P/N 70-0050-B24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549400  (XMD P/N 70-0050-A22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549320  (XMD P/N 70-0050-222)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548590  (XMD P/N 70-0050-A16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548240  (XMD P/N 70-0050-312)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548550  (XMD P/N 70-0050-616)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549450  (XMD P/N 70-0050-F22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549380  (XMD P/N 70-0050-822)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548790  (XMD P/N 70-0050-E18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548960  (XMD P/N 70-0050-F20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548570  (XMD P/N 70-0050-816)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548830  (XMD P/N 70-0050-220)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548260  (XMD P/N 70-0050-512)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548560  (XMD P/N 70-0050-716)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548540  (XMD P/N 70-0050-516)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549430  (XMD P/N 70-0050-D22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548220  (XMD P/N 70-0050-112)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548620  (XMD P/N 70-0050-D16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548310  (XMD P/N 70-0050-A12)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549460  (XMD P/N 70-0050-G22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548290  (XMD P/N 70-0050-812)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548420  (XMD P/N 70-0050-914)
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549310  (XMD P/N 70-0050-122)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548440  (XMD P/N 70-0050-B14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548810  (XMD P/N 70-0050-G18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M005489350  (XMD P/N 70-0050-522)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548860  (XMD P/N 70-0050-520)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549560  (XMD P/N 70-0050-C24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549600  (XMD P/N 70-0050-G24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548610  (XMD P/N 70-0050-C16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548320  (XMD P/N 70-0050-B12)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548690  (XMD P/N 70-0050-418)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548890  (XMD P/N 70-0050-820)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548660  (XMD P/N 70-0050-118)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548270  (XMD P/N 70-0050-612)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548480  (XMD P/N 70-0050-F14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548450  (XMD P/N 70-0050-C14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548630  (XMD P/N 70-0050-E16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548710  (XMD P/N 70-0050-618)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549540  (XMD P/N 70-0050-A24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549420  (XMD P/N 70-0050-C22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548670  (XMD P/N 70-0050-218)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548510  (XMD P/N 70-0050-216)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548770  (XMD P/N 70-0050-C18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548740  (XMD P/N 70-0050-918)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548930  (XMD P/N 70-0050-C20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549580  (XMD P/N 70-0050-E24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548680  (XMD P/N 70-0050-318)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548780  (XMD P/N 70-0050-D20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549520  (XMD P/N 70-0050-824)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548820  (XMD P/N 70-0050-120)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548300  (XMD P/N 70-0050-912)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548600  (XMD P/N 70-0050-B16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549570  (XMD P/N 70-0050-D24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548400  (XMD P/N 70-0050-714)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Nationwide Distribution including AL  CA  CT  FL  IN  KS  LA  MA  MD  MI  MN  MO  MS  NE  NY  OH  OR  PA  TX  WA  WI
Syngo Plaza Picture archiving and communication system.  Software only.  PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized.  Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.
Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
Single Lumen Pressure Monitoring Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
A manufacturing process may lead to catheter tip fracture and or separation.  Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids
Single Lumen Central Venous Catheter Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Femoral Artery Pressure Monitoring Catheter Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
The American National Red Cross - Southern Region
Fresenius Medical Care Renal Therapies Group, LLC
US Distribution to states of: KS, LA, MS, OK, and TX.
Fresenius Naturalyte Liquid Acid Concentrate  Catalog Number: 08-2301-3    Intended Use: Acid Concentrate for Bicarbonate Dialysis
On the label calcium (Ca)  listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Lot Number: 15STAC072  Exp Date: 2017-12-31
Distributed US (nationwide) and in Australia.
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW).     Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050.
Worldwide Distribution-US (nationwide) and the countries of   Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur.  This has also an effect for false low PT INR values.  These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients.  The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED);  IVD --- Device Listing D060801
U.S. consignees nationwide.*** Foreign consignees in: Canada.
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner.  It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.
Potential for the Symbiq pole clamp assemblies to be missing the  rubber stop pad.
Bulk Macadamia Nuts - (salted, unsalted; whole and pieces)  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 5 lb. bag.    NO UPC number.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704
All lots - approximately 5676 total pounds of nuts and nut butters
IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.
Izzie Macs! Macadamia Nuts - Unsalted.  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 6 oz. plastic bag and 16 oz. plastic bag.    UPC - 6 oz.: 689076793575;  UPC 16 oz.: 689076792776.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704
Izzie Macs! Macadamia Nuts - Salted.  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 6 oz. plastic bag and 16 oz. plastic bag.    UPC - 6 oz.: 689076792677;  UPC 16 oz.: 689076792974.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704
Baby Bruddah's Mac Nut Buttah;  Certified Organic by International Certification Services Inc.. From the Big Island,   A raw food.  Sold in 12 oz. plastic tub.    UPC number:  753182242019    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704
Baby Bruddah's Chocolate Mac Nut Buttah;  Certified Organic by International Certification Services Inc. From the Big Island,   A raw food.  Sold in 12 oz. plastic tub.    UPC number:  75318224204    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704
error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.
Two distributors with locations in CT, CA. PA, SC and NJ.
Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted.  Organic, gluten free, non gmo, vegan;  NET WT. 4.5 oz (127 g);  UPC: 10897580000707;    Mary's Gone Crackers, Inc.  199 Kentucky St., Gridley, CA 95948
Gluten Free product may have gluten levels above the >20 ppm limit  in FDA regulations for gluten free products.
US Nationwide in the states of CA, NY, and OR
Flow-i Anesthesia System    Product Usage:  The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues.    Only the Model C20 is affected in the US.
Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico.    **Consumer Recommended Depth - Consumers/User**
Hill-Rom Bariatric Power Recliner, Product Model # P9096   Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:   L341RW9151 through P070RW0812
Worldwide Distribution, including US Nationwide.
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286.  Spinal cord stimulation leads.  Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada
LDPE is softer than the two mating materials o
Becton, Dickinson and Company, BD Biosciences
Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.
BD FMC7 FITC: Model 430918.  FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.    Product Usage:  Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
Becton,  Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed  on the vial label.
Model number: 340918: Lot number: 5341918.  Incorrect  expiry date on label 03/31/2017. correct expiry should be 6/30/16.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, Gamma K-Wire 3.2x450 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 K-Wire, 3.2x400mm, Recon    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-3030S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-1250S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 K-Wire, 3x285 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 0190-2000S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, Gamma Guide Pin, 4x400 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0083S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.
Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Domestic: IL, IN, KY, MI, OH, WI    Foreign: None
Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons
House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid.
UPC Code 13733 61945 and marked Best By November 21, 2016
Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut,  net weight 8 oz. , one unit per package, packed in clear clamshell,  expiration date 12/22/15
215 packages of fudge were produced and distributed
Jody's Inc. received a few notifications from people who bought the fudge as part of a school fund raiser that the fudge had mold on it.  The expiration date of the fudge is 12/22/15, and it should not be growing mold yet.  The firm immediately recalled  the fudge.
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Flexor Check-Flo Introducer, Catheter introducer,   Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC    Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
Convenience Kits from Centurion contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. According to the RyMed Technologies recall notice, the recall was initiated due to the identification of a component molding  abnormality that may lead to female luer threads to crack, leading to potential for the mating tubing set to
The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Stryker Aero-AL Impaction handle Catalog Number 48921007.  Stryker Spine Manufactured by : Stryker Spine SAS France     Used to facilitate insertion of the Aero-AL cage into the disc space.
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965    Product  Usage:  The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
The clip in the applier may be missing a boss.  A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
Distributed in the states of AZ, CA, MA, MI, OH, and VA.
EkoSonic Endovascular System, Catalog Number 500-56112.    It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System.     During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site.     The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface  Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
date or BUD (Before Use Date) that may be longer than intended.
Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania,  Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka,   Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Philips IntelliVue Module Measurement X2		  Model: M3002A
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound  when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
Philips IntelliVue Measurement Module X1   Model: M3001A
Blood product, collected from a donor who travelled in a malarial endemic country within 12 months of donating, was distributed.
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India.  Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ  08534. NDC: 68382-156-06.
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
US Nationwide Distribution including Puerto Rico.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator.  Ventilation.
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag.
322 Cases x 8 bags of 32 oz. each = 2576 32 oz. bags.
Undeclared Allergens: milk, eggs, wheat and fish.
Worldwide Distribution - USA (nationwide) Distribution
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer .  This is a  Analytical X-ray system
US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
software for Syngo Dynamics     a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN  38101-2026, UPC 0 70596 00422 5.
Microbial Contamination of a Non-Sterile Products:   The product had a positive Staphylococcus aureus test result.
Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.
Mammomat Inspiration with Tomosynthesis functionality
A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.