Direct US customers:  IN and OH.  NO foreign.
causing misuse and feed contamination.  No labeling, all products in tanker trucks.
causing misuse and contamination in animal feed.
bulk custom ordered animal feed for swine
LaCrosse, IN up to 13,644 ton; Reynolds, IN up to 8,383 ton; Flora, IN up to 8,553 ton
Co-Alliance is voluntarily recalling the feed manufactured at the LaCrosse facility between July 1, 2014-September 19, 2014 due to an ongoing Class I recall of the grease that was used in manufacturing the animal feed. The grease is an industrial waste by-product from the manufacturing process for Lasalocid, which is not approved for swine feed.
bulk  custom feed produced and distrbuted between July 1, 2014-September 19, 2014
Alfalfa Hay,  Square-baled, Bound with reddish-orange twine, weighing approximately 70 lbs.
Product was found to be contaminated with blister beetles which can be deadly to horses.
Product distributed on or after August 11, 2015
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Bertagni product was distributed directly in CA, IL, MI, MN, NY, OH, and OR between 5/11/15 and 11/12/15.    Meijer product was distributed in IL, IN, KY, MI, OH, and WI between 6/12/15 to 10/26/15.
Meijer frozen Butternut Squash Ravioli, product is packaged in a paper box, net weight 12 oz., UPC 760236398479
Meijer frozen Butternut Squash Ravioli is recalled because  product may contain undeclared cashew and almond.
Expiration date: 11/5/2016  Lot code: 519 E
Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139.
Bertagni fresh Sweet Butternut Squash Ravioli is recalled because the products may contain undeclared cashew and almond.
Expiration dates from 8/3/16 to 1/29/17.  Lot codes: 506B, 508C, 511D, 512C, 513B, 516B, 520A, 522B, 522F, 523B, 523C, 529C, 530F, 531F, 535C, and 536A.    The lot code is interpreted as below:   Example 506B: 5=2015;  06= week 6 of the year; B= second day of the week (Tuesday)
Distributed nationwide throughout the U.S.A.      Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.
Raw Meal Organic Vanilla Spiced Chai Powder; Organic Shake and Meal Replacement; 909 g, 455 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.
Total (including all flavors) of 422,923 bottles/units
Products possibly contaminated with Salmonella
Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each).  Packaged in plastic bottle with colored label.
Raw Meal Organic Chocolate Powder; Organic Shake and Meal Replacement; 986 g, 493 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.
Raw Meal Organic Original Powder; Organic Shake and Meal Replacement; 908 g, 454 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit.     Product  Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579),  20 cards/kit.     Product  Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability    The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz.  The responsible name on the label is Nuwati Herbals Inc., House Springs, MO.
CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii.  Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.
Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and  Ascom Unite Connect for Nurse Call version 2.2.0
Worldwide distribution -  US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge    The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results.  The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.
Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.
Nationwide Distribution to FL, MO, and WV.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000  Used to rotate implant into position
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Cholesterol_2 (CHOL2): 74719  Cholesterol_concentrated (CHOL_c): 74718
Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
Device Listing: Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated  (UA_c) - D033081, Catalog # 74715
Dimension Assays: Direct HDL Cholesterol (AHDL)
Device Listing: D 044702 - Direct HDL Cholesterol (AHDL), Catalog # DF48B
Device Listing: D011436 Uric Acid (URCA), Catalog # DF77
Dimension Vista  Assays: Direct HDL Cholesterol (AHDL)
Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A
Dimension Vista  Assays: Enzymatic Creatine (ECRE)
Device Listing: D089144 Enzymatic Creatinine (ECRE),  Catalog # K1270A
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Device Listing: Direct HDL Cholesterol: D126055; Catalog # 74073
Device Listing: D089144(Enzymatic Creatine (ECRE) Catalog # DF270B
Dimension Vista Assays: Triglycerides (TRIG)
Device Listing: D011436 - Triglycerides (TGL),  Catalog # DF69A
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Device Listing: D126071, Triglyceride_2, Catalog # 74082  Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084
Advia Chemistry Assay: LDL Cholesterol, Direct
Device Listing: LDL Cholesterol, Direct: D126056; Catalog # 74028
Dimension Vista Assays: Uric Acid (URCA)
Device Listing: D011436 - Uric Acid (URCA),  Catalog # K1077
Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721
Device Listing: D011286 Triglycerides (TGL), Catalog # DF69A
Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
Covidien Kangaroo Connect Enteral Feeding Pump  Item Number: 384400 (US)    Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
Covidien Kangaroo Connect Enteral Feeding Pump  Item Number: 584400 (OUS)    Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Failed Dissolution Specifications; three month stability time point.
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.
20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments
9,817 batteries (8,170 with monitors and 1,647 as spare parts)
20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
Product # 016400; All SNs, irrespective of production date. Product # 010520; All SNs with production date starting 14.14
Imperial Choice Mandarin Oranges Broken Segments in Light Syrup; Net WT. 11 oz.; Imported by Acme Food Sales, Seattle, WA 98108; Product of China;     4200/01029; PRO: DEC 21, 2013; Best By: Dec 21, 2016
Greater Pittsburgh Community Food Bank is announcing  a voluntary recall of one lot of Imperial Choice Mandarin Oranges Broken Segments in Light  Syrup because some of the cans from this lot may leak, bulge or burst open. The product may  be contaminated by spoilage organisms or pathogens, which could lead to serious or life threatening  illness if consumed. This recall only affects cans marked wi
U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR    Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.     Distributed individually and in kits.
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Granna's 808 French Toast, Diced Potatoes, Mandarin Oranges in three compartment black, plastic tray, stored frozen
Product has whey listed on the label, not milk.
Product Code: 808; Best By Dates 04/05/2016 through 04/05/2017
Worldwide Distribution -  USA (nationwide) and to the countries of :  Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey,  United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.
ADVIA Centaur CP Immunoassay System,  Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers.    This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Classic Pesto Sauce (with a twist) is recalled because Parmesan cheese is declared but milk is not declared on label.
Lemon Pesto Sauce recalled because parmesan cheese is declared but milk is not declared on label.
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Discoloration:  presence of atypical yellow discoloration of the solution .
Hamilton G5 with software version between v2.41, v2.42, v2.50.  Catalog number: 1590001 and 1590002.    Anesthesiology:  Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Failed Impurities/Degradation Specifications; 12 month stability time point
Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally  to Argentina, Australia, Austria,  Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait,  Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia,  Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab  Emirates, United Kingdom
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V  The product is a thermal regulating system indicated for monitoring and controlling patient temperature
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM).  This premature coin cell battery drainage could render the device unresponsive upon System startup.
US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
in the system setting - scanner options.
Launcher Guiding Catheter  Model #LA6EBU30.  Used in the coronary or peripheral vascular system..
Mallinckrodt Evac Tracheal Tubes  Model #124170-MALLINCKRODT & 124175
Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA   and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C    Product Usage:  Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
Distributed US (nationwide) and in  Australia, Switzerland, Netherlands, Spain and Sweden.
CinchLock SS Knotless Anchor with Inserter;  Model number CAT02462;     Orthopedic:  The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking  upon deployment of the anchor.
CinchLock Flex Knotless Anchor with Inserter;  Model number CAT02643;    Orthopedic:  The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking  upon deployment of the anchor.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device).  PIN 19960
Incorrect component used to manufacture distal femoral replacement.
Device Identifier: PIN 19960, Lot: 19960
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
Bradshaw is recalling 1st Generation Axial Torque Limiting Driver because the firm became aware of a component failure that had the potential to cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Potential of an allergic reaction in a patient with nickel sensitivity.
Nationwide U.S. distribution through online sales.    No foreign distribution.
Undeclared whey protein containing the allergens of milk and soy lecithin.
Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Instructions for use  booklet may puncture the outer Tyvek lid.
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Instructions for use booklet may puncture the outer Tyvek lid.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC  Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
AL, AZ, CA, CO, CT, FL, HI, IL, IN, LA, MD, MA, MO, NY, NC, OH, TN, TX, VT, WA
Galileo Echo automated blood bank analyzer, with potentially incorrect Color Level settings, were identified and corrected.
Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.