Distributors in  WA, CA and NY - product sold Nationwide and via internet sales at  Pet Stores, Pet Boutiques, Groomers and Veterinarian Offices.
Jump Your Bones Roo Bites (Cubes) - Packaged in 80g/2.82 oz. including samples of .32 oz.plastic bags in a re-sealable container
The Colorado Department of Agriculture collected a sample and found that it was positive for Salmonella. They submitted the Salmonella isolate to the FDA for further identification.
No codes/lots #'s or Best By or Expiration date on the packages only UPC 63633010041
Big Bark All Natural Beef Jerky Treats for Dogs was distributed primarily in Colorado, with some product distributed in Wyoming, Utah, Oklahoma, and Arizona through Nor-Sky Pet Supply LLC to independent pet stores.
Big Bark All Natural Beef Jerky Treat for Dogs, Guaranteed Analysis, Crude Protein 65%, Crude Fat 8.0%, Crude Fiber 2.0%, Moisture 10.0%, Ingredients: Dehydrated Beef Heart Made in USA Grill-Phoria LLC 1082 North Denver Ave, Loveland, Colorado 80537, Item #NS01701, 3.5 oz (99 g), 8 17894 01701 0
Grill-Phoria of Loveland, Colorado is recalling certain Big Bark All Natural Beef Jerky Treats for Dogs due to potential contamination with Salmonella.
No lot codes are listed on the product.  Product is packed in 3.5 oz resealable plastic pouches.  It was manufactured and distributed from 9/20/14 through 1/02/15.
Product distributed to distributors in CA and IL
Nutrisca Chicken and Chick Pea Recipe Dry Dog Food, Net Wt. 4 lbs.
Specific lots of Nutrisca Chicken and Chick Pea Recipe Dry Dog Food have the potential to be contaminated with Salmonella.
First five digits of Lot Codes:  4G29P, 4G31P, 4H01P, 4H04P, 4H05P, 4H06P.  Best By Dates:  Jul28 16, Jul 30 16, Jul 31 16, Aug 03 16, Aug 04 16, Aug 05 16.
Eastern Colorado Recycling dba Triple A Brand Meat Co.
Nevada, Minnesota, and Louisiana.  No foreign/govt/VA/military consignees.
Eastern Colorado Recycling CO. 43465 Highway 24, Burlington, CO 80807, 25 pound cardboard boxes, 5 packages per case, frozen
Triple A Brand Meat Company is recalling Horse Chunk due to potential contamination with barbiturates.
Lot number indicates the date of production: OCT 22 2014, OCT 27 2014, NOV 15 2014
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
US: RI, MA, VT, PA, OH, GA, FL, TX, IL, CO, CA NM.
Vital Essentials Frozen Beef Tripe Patties, 6 lb package (heat sealed bag), 4 per case, product code #3809, UPC 33211 00809.  Vital Essentials Frozen Tripe Treat Nibblets, 3 lb package (heat sealed bag), 6 per case, product code #3904, UPC 33211 00904.
Carnivore Meat Company LLC is recalling Frozen Beef Tripe Patties (Lot Number 10930) and Frozen Beef Tripe Nibblets (Lot Number 10719) because of the presence of Listeria monocytogenes in the product.
Tripe Patties - lot# 10930, product code# 3809, Best by date 20160210.  Tripe Nibblets lot# 10719, Product code# 3904, Best by date 12022015.
total about 4200 lbs. (700 lbs. of 50 blocks and 3000 lbs. of 10 lbs. chubs)
is recalled due to contamination with Salmonella.
Jul12015B.    The code is interpreted as manufacture date (07/01/15) and shift (B)
Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538    Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.
Philips Electronics North  America Corporation
Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
INTEGRIS BH5000; Model Number: 72247    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers:  722026 722010 722003 722002 722001    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
INTEGRIS Allura 9 (biplane); Model Number: 722021    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS BN/BV3000; Model Number: 72240    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS CV; Model Number: 722030    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS Allura 15-12 (biplane); Product Code: 722044    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS BV5000: Model Number: 72249    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS H3000; Model Number: 72238    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS HM3000; Model Number: 72239    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Allura Xper FD10/10; Model Numbers: 722027 722011 722005    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
INTEGRIS H5000; Model Number: 72246    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS BH3000; Model Number: 72242    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS BV3000 MONO; Model Number: 72241    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Allura Xper FD10 OR Table; Model Numbers: 722033 722022    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
INTEGRIS V5000: Model Number: 72248    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS Allura 15-12 (mono); Model Number: 722043    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
INTEGRIS V3000; Model Number: 72243, 72244, 72245    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
The affected Harveys stores (56 stores) are located in Florida, Georgia, and South Carolina.  The affected Winn-Dixie Stores (85 stores) are located in Florida and Georgia.
Cookie Platter Containing Oatmeal Rasin Cookies packaged in plastic container, 48-count and 36-count
21,600 total Baked Oatmeal Raisin Cookies
Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count
Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count
Tonkutsu Ramen, Net Wt. 12 oz. Made by Sun Noodle Honolulu, HI 96819/Rancho Domingo, CA 90220/Teterboro, NJ 07605  UPC 0 85315 40003 5  PACKAGED IN PLASTIC CLEAR CLAMSHELL
Tonkutsu Ramen may contain undeclared eggs.
U.S. distribution to the following; TX, LA, FL  No foreign distribution.
Dockside Classics  4 Gourmet  Crab Cakes  Net Wt. 12 oz.  UPC: 045425167143
The product may not have been transported at a safe temperature.
Dockside Classics  4 Gourmet  Lobster Cakes  Net Wt. 12 oz.  UPC: 045425167143
Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network.    Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.    The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation.  On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
Apheresis Red Blood Cells, Leukocytes Reduced
Misbranded red blood cells, were distributed.
Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and Wisconsin
Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL, NET WT 8 OZ, UPC 7142909849
AZ, GA, MA, MS, OH, VA, CA, IA, MD, NH, OK, VT, CO, IL, ME, NJ, OR, WA, CT, IN, MI, NM, PA, WI, DE, KS, MN, NV, RI, WY, FL, KY, MO, NY and TX.
Dove Chocolate Assortment Snowflakes Net. Wt. 24.0 oz. Distributed by Mars Chocolate na, llc Hackettstown, NJ 07840-1503 USA  UPC 400050521
Dove  Chocolate Assortment Snowflakes may contain undeclared peanuts, what and egg ingredients.
Code and Best Before Dates include:  537CG4PA30: Best Before 9/2016  537DG4PA30: Best Before 9/2016  538AG4PA30: Best Before 9/2016  538AM4PA30: Best Before 9/2016  541AG4PA20: Best Before 10/2016  542EM4PA20: Best Before 10/2016
Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a cardboard box
Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box
Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box
Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box
Signature Breads Frozen Parbaked French Dinner Rolls 22251; 280 Units - 1 OZ, NET WT. 17.5 LB (7.93 kg), in a cardboard box
Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box
Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box
Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box
U.S. distribution in CA only (Los Angeles and San Diego).  No foreign distribution.
Masago Lake Smelt Roe  6 oz.  UPC Code:4866010101
Product contains undeclared soy and wheat.
Worldwide Distribution - US Distribution to the states of :  AK, AL, CA, CO,  FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
U.S. distribution to the following:  Distributor- IL  Retail- MN, OK, ND, WI, IA, KS, CA, IL, MD, TN, IA, NM, FL, GA  Online Consumers- FL, PA, VA, LA, CA, MD, NC, TX, RI, NY, MA, OH, ME, TN, GA, AK, MI, CT, NJ, WA, IL, IA, OK
This Kid Saves Lives Chocolate Chip  UPC #10858497004097  UPC# 858497004090
This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip because the product contains whey protein and does not identify milk.
Inner pack(5 bar carton) - BEST BY APR APR2916 and BEST BY JUL2816    Case(8 inner packs) - BEST BY APR2916 and BEST BY JUL2816
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]  General Hospital Use.
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging].    General Hospital Use.
Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.
ACIST Medical Systems, BT2000 Automated Manifold Kit   (SKU 014613) and CPT2000 (SKU 014623)  Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico.    The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST).    To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
Reports related to ingress of air into the manifold.
Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Emergency Transport Ventilator  Oxylog 2000 Plus Ventilator  Catalog Number: 5705080.    Volume controlled emergency and transport ventilator with pressure support.
was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
Emergency Transport Ventilator  Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator  Catalog Numbers: 2M86300/2M86965 and 5704813/5704831.    Volume controlled and pressure-controlled emergency and transport ventilators.
402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)
All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
Signature Cafe Traditional Stuffing;  Turkey Broth, Seasoned Bread Crumb Mix, Celery, Yellow Onion.  Net WT. 39 oz. (2 lbs 7 oz) 1.1 kg.  Perishable, Keep refrigerated.    UPC 21130-08320     Distributed by Lucerne Foods Inc.  PO Box 99  Pleasanton, CA  94566
190 cases (4 X 39 oz. packages per case)
Signature Cafe Traditional Stuffing may have the incorrect ingredient and nutritional label that does not declare the allergens soy, milk and wheat.
Lot Code of TFPV351;  Use By Date of 12/26/2015
Denali Filter-Jugular/Subclavian DL950J  Denali Filter-Femoral Delivery DL950F.   Intravascular filters.
IFU missing contraindications:   Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Product Code: DL950J  Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699    Product Code: DL950F  Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Baxter, RAPIDFILL Syringe Strip, 10 ml.  For use with RAPIDFILL Automated Syringe Filler (ASF)
Baxter Healthcare has issued an Urgent Product Recall communication for all lots of RAPIDFILL Syringe Strips due to lack of evidence supporting the packaging claim for 12-month shelf life on released product.
Worldwide Distribution-US (nationwide) including the states of   PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of  Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
AQURE System; Model Number: 933-599.  The AQURE System manages blood gas and immunoassay analyzers.
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR,  AU,  BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit)    Product Usage:  This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
HemosIL Plasminogen, Part No. 0020009000, IVD.  Instrumentation Laboratory Company.   Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Lot No. N0455811, Expiration Date 03/31/2017
Worldwide Distribution-US (nationwide) including the states of  AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.
Synthes Small Electric Drive (SED).  For use in general traumatology.
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood products, which did not meet acceptable product specifications, were distributed.
Distributed US (nationwide) and in Canada.
PS-500 Scope Warmer; 10 units per box.    Pre-heating scope for laparoscopy surgery.
Damage to package seals potentially compromising sterility.
U.S. distribution to the following; CA, CO, AZ, WA, OH, NC, AL, NJ, CT, IL, HI, NY, TX, OR, FL, GA, NM, VA, MD, LA, MA, MI, ME, MN, PA, NC, AK, KS    Foreign distribution to the following: CA
Tong Ren Tang  Shenjing Shuairuo Wan  Herbal Supplement  240 pills    UPC Code: 6 904579 129602    Distributed by: Solstice Medicine Company
Madison One Acme, Inc. dba Solstice Medicine is recalling Tong Ren Tang Shenjing Shuairuo Wan because it contains the unapproved dietary ingredient human placenta which may transmit disease.
US: Nationwide Distribution in the states of FL, OH, and MO.
DS/US Proton Feature with Pinnacle3  Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
Blood products, in which NAT testing was performed incorrectly, were distributed.
Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.
U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.
ABX PENTRA Lactic Acid CP ref. A11A01721  reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
ABX PENTRA Glucose PAP CP ref. A11A01668  reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
ABX PENTRA Uric Acid CP ref. A11A01670  is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
Blood product, labeled RBC antigen negative tested RBC antigen positive, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
2,000 cases (100 individual units per case)
Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
Blood product collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood and Blood Products for Reprocessing
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed
Lifesouth Community Blood Centers - Montgomery Region
Blood product, with a low pH, was distributed.
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope    Product Usage:  This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
API ZYM Bx2 (Ref 70493)    Product Usage:  ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
Discrepant identification results related to API identification strips.  These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.
Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.
Astral 100, 150  Model: 27001, 27003  In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Labeling: label error on declared strength.
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.