June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical: 27
Severe: 157
High: 246
Moderate: 293
Low: 35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 21% are Severe.

Which agencies issued them

301–400 of 758

ModerateFDA (Devices)·Z-2498-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2540-2017·2017-06-21
Cook Inc. Recalls Vue Optic Endoscopes Due to Insufficient Reprocessing Instructions
Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.
Product
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Category
Medical Device
Distribution
6 states
ModerateFDA (Drugs)·D-0908-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 144 bags of Potassium Phosphate in 0.5% Dextrose because the product label incorrectly states a volume of 150 mL instead of the actual 100 mL.
Product
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2430-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that may expose the product to moisture and cause antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN82), REF 413439, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2559-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants and accessories because packaging design verification tests failed.
Product
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2427-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2468-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2361-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2342-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram-Positive Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram-Positive identification cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2483-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2521-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2582-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary rod implants and accessories because packaging design verification tests failed. The recall affects 9,867 units distributed worldwide.
Product
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2362-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2489-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2584-2017·2017-06-21
Acumedia Recalls Palcam Supplement Due to Possible Bacillus Contamination
Acumedia Manufacturers, Inc. is recalling Palcam Supplement (PN 7987) due to possible contamination with Bacillus spp. The product is used for Listeria enrichment.
Product
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2425-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2549-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories due to packaging design verification test failures.
Product
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2418-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2428-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-P625), REF 413727, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2522-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2470-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2451-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2389-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2332-2017·2017-06-21
Arrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2495-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2555-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action covers specific lots distributed worldwide.
Product
Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2577-2017·2017-06-21
Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile hip implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2384-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2526-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2471-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2503-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2534-2017·2017-06-21
Cook Inc. Recalls Pereyra-Raz Ligature Carriers Due to Inadequate Reprocessing Instructions
Cook Inc. is recalling 257 Pereyra-Raz Ligature Carriers because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Pereyra-Raz Ligature Carrier
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2536-2017·2017-06-21
Cook Inc. Recalls Stamey Needles Due to Insufficient Reprocessing Instructions
Cook Inc. is recalling 698 Stamey Needles because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Stamey Needle
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2569-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 9,867 sterile knee joint implants because packaging design verification tests failed. The action affects units distributed worldwide.
Product
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2400-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2516-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2402-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, risking antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2454-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2465-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that may expose the product to moisture, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2515-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P650), IVD, REF 421296, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2452-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2490-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2447-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Container Integrity Issues
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2586-2017·2017-06-21
Medtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
Medtest Holdings is recalling specific lots of Pointe Scientific Hitachi Total Bilirubin R1 Reagent due to decreased reactivity of the R1 component.
Product
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro…
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2426-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2456-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N286), REF 414778, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2329-2017·2017-06-21
Arrow International Recalls Introducer Kits Due to Potential Sterility Compromise
Arrow International is recalling Introducer Kits and Arrow PSI Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2512-2017·2017-06-21
Biomerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Streptococcus Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2436-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2404-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2464-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2520-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2494-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2463-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN93), REF 414985, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2374-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2399-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N217), REF 413080, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2500-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2345-2017·2017-06-21
Biomerieux Recalls VITEK 2 Neisseria-Haemophilus Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Neisseria-Haemophilus identification cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotics.
Product
VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2593-2017·2017-06-21
Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 445 units of sterile-packaged VERSA-FXII SC TUBE PLT implants due to packaging design verification test failures.
Product
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2380-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2349-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2493-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture to degrade antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2448-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N272), REF 414164, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2371-2017·2017-06-21
Global Commodities Recalls Dry Figs for Undeclared Sulfites
Global Commodities Inc. is recalling 93 cases of Aahu Barah dry figs due to the presence of undeclared sulfites. The product was distributed in New York, New Jersey, Massachusetts, and Virginia.
Product
AAHU BARAH, DRY FIG, NET WT. 1 LB, PRODUCT OF PAKISTAN
Category
Food
Distribution
4 states
ModerateFDA (Devices)·Z-2524-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2514-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2594-2017·2017-06-21
Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 510 units of sterile-packaged VERSA-FX II STD TUBE implants because packaging design verification tests failed.
Product
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2505-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2406-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2154-2017·2017-06-21
Philips DigitalDiagnost 3.1.x X-Ray System Recalled for Performance Issues
Philips is recalling DigitalDiagnost 3.1.x X-Ray Systems in the US due to a potential issue that may affect equipment performance under certain conditions.
Product
Philips DigitalDiagnost 3.1.x X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2359-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2373-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2579-2017·2017-06-21
Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile porous femoral stems because packaging design verification tests failed. The action affects units distributed worldwide.
Product
Por fullct fem st 17x200mm, Sterile,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2459-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2379-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2477-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N311), IVD, REF 416952, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2333-2017·2017-06-21
Arrow International Recalls Central Venous Access Kits Due to Packaging Seal Issues
Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2392-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2346-2017·2017-06-21
Biomerieux Recalls VITEK 2 Anaerobic Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Anaerobic and Corynebacteria identification cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0902-2017·2017-06-21
Safecor Health Recalls Calcium Carbonate and Vitamin D3 Tablets
Safecor Health is recalling 25 bottles of Calcium Carbonate and Vitamin D3 tablets due to CGMP deviations. The product was distributed in Massachusetts and New York.
Product
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-2455-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2376-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2485-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2461-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Fungal Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2551-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories due to packaging design verification test failures.
Product
Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2449-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2506-2017·2017-06-21
Biomerieux Recalls VITEK 2 Fungal Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Fungal Susceptibility card (AST-YS08), IVD, REF 420739, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2351-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2390-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton. .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2385-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2367-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity may be compromised, allowing moisture exposure that could degrade antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2572-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile knee implants because packaging design verification tests failed. The recall covers units distributed worldwide.
Product
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2589-2017·2017-06-21
Smiths Medical Recalls CADD High Volume Administration Sets Due to Incorrect Instructions
Smiths Medical is recalling 7,035 CADD High Volume Administration Sets because they contained the wrong instruction manual insert.
Product
CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2397-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2443-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN86), REF 413942, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2513-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2421-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide

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