June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical: 27
Severe: 142
High: 261
Moderate: 293
Low: 35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 19% are Severe.

Which agencies issued them

301–400 of 758

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-2478-2017·2017-06-21
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-N314), IVD, REF 417027, 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 (Drugs)·D-0903-2017·2017-06-21
Safecor Recalls Acyclovir 400mg Tablets Due to Manufacturing Deviations
Safecor Health is recalling 601 bottles of Acyclovir 400mg tablets distributed in Massachusetts and New York due to CGMP deviations.
Product
Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
Category
Drug
Distribution
2 states
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-2325-2017·2017-06-21
Pentax Video Cytoscopes Recalled for Loose Suction Arms
Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.
Product
Video Cytoscopes
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 (Devices)·Z-2480-2017·2017-06-21
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-N317), IVD, REF 417558, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2508-2017·2017-06-21
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-P648), IVD, REF 420857, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2563-2017·2017-06-21
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 affects 9,867 units distributed worldwide.
Product
Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
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-2564-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nail Implants
Zimmer Biomet is recalling sterile femoral intramedullary nail implants due to packaging design verification test failures.
Product
Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2557-2017·2017-06-21
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 recall covers specific lots distributed worldwide.
Product
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2453-2017·2017-06-21
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-P628), REF 414534, 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-2475-2017·2017-06-21
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-N303), IVD, REF 416590, 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-2377-2017·2017-06-21
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-P619), REF 411944, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2356-2017·2017-06-21
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-P584), REF 22252, 20 cards per carton.
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-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-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-2414-2017·2017-06-21
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-N244), REF 413393, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
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-2598-2017·2017-06-21
Zimmer Biomet Recalls Sterile-Packaged Femoral Intramedullary Nails
Zimmer Biomet is recalling sterile-packaged femoral intramedullary nails due to packaging design verification test failures.
Product
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MM
Category
Medical Device
Distribution
50 states
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-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-2474-2017·2017-06-21
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-N301), IVD, REF 416274, 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-2375-2017·2017-06-21
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-GP71), REF 410750, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2568-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Design Failures
Zimmer Biomet is recalling sterile knee joint femorotibial implants because packaging design verification tests failed. The recall affects 9,867 units distributed worldwide.
Product
Segmental fluted stem, 17x190mm 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-2552-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories because packaging design verification tests failed.
Product
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
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-2479-2017·2017-06-21
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-N315), IVD, REF 417426, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
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-2556-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile femoral intramedullary nails because packaging design verification tests failed. The recall affects units distributed worldwide.
Product
Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-2560-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
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-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 (Devices)·Z-2519-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling 474 cartons of 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-N356), IVD, REF 421352, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2484-2017·2017-06-21
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-N322), IVD, REF 418489, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2372-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Streptococcus Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Streptococcus Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 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-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-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-2420-2017·2017-06-21
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-GN71), REF 413402, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2567-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile knee implants due to packaging design verification test failures. The field action affects units distributed worldwide.
Product
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2518-2017·2017-06-21
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-N355), IVD, REF 421351, 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-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-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-2583-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rods Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile intramedullary rods and accessories due to packaging design verification test failures.
Product
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2434-2017·2017-06-21
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-N253), REF 413722, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2360-2017·2017-06-21
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-P597), REF 22298, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2353-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2416-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux 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-N246), REF 413395, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2476-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2407-2017·2017-06-21
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 issues may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 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-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-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-2458-2017·2017-06-21
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-GN91), REF 414780, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2344-2017·2017-06-21
Biomerieux Recalls VITEK 2 Bacillus Identification Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Bacillus identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 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 (Drugs)·D-0898-2017·2017-06-21
Hospira Recalls Levophed Injection Due to Foreign Stopper Observation
Hospira is recalling specific lots of Levophed (norepinephrine bitartrate) injection after a foreign stopper was observed during packaging.
Product
LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2574-2017·2017-06-21
Zimmer Biomet Recalls Segmental Fluted Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile segmental fluted stems because packaging design verification tests failed. The recall covers 9,867 units distributed worldwide.
Product
Segmental fluted stem, 18x250mm bwd, Sterile,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2537-2017·2017-06-21
Cook Inc. Recalls Clarke-Reich Laparoscopic Knot Pushers Due to Reprocessing Issues
Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Product
Clarke-Reich Laparoscopic Knot Pusher
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2432-2017·2017-06-21
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-N249), REF 413572, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2403-2017·2017-06-21
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-N232), REF 413116, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2394-2017·2017-06-21
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-N208), IVD, REF 413062, 20 cards per carton.
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-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-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-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-2350-2017·2017-06-21
Biomerieux Recalls VITEK 2 Fungal Susceptibility Cards Due to Container Integrity Issues
Biomerieux Inc is recalling VITEK 2 Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 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-2497-2017·2017-06-21
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-N331), IVD, REF 418675, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2395-2017·2017-06-21
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-N213), REF 413063, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2378-2017·2017-06-21
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, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2324-2017·2017-06-21
Pentax Video Bronchoscopes Recalled for Loose Suction Arms
Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The action retrospectively documents corrections made in 2010-2011.
Product
Video Bronchoscope
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 (Drugs)·D-0919-2017·2017-06-21
American Pharmaceutical Ingredients Recalls Estrone USP Due to cGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding due to cGMP deviations and lack of quality assurance.
Product
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
6 states
ModerateFDA (Drugs)·D-0915-2017·2017-06-21
Pharmedium Recalls Vancomycin Injection Bags With Incorrect Volume Labeling
Pharmedium Services is recalling 60 bags of Vancomycin HCl injection because the label incorrectly states 500 mL instead of the actual 300 mL volume.
Product
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0900-2017·2017-06-21
Safecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations
Safecor Health is recalling 66 bottles of Acetaminophen 325mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed in Massachusetts and New York.
Product
Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
Category
Drug
Distribution
2 states
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-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-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-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-2387-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall
Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2595-2017·2017-06-21
Zimmer Biomet Recalls R-F IM Nails Due to Packaging Design Failures
Zimmer Biomet is recalling 3,856 sterile-packaged R-F IM Nails because packaging design verification tests failed. The action covers units distributed domestically and internationally.
Product
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2576-2017·2017-06-21
Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile hip implants because packaging design verification tests failed. The recall covers units distributed worldwide.
Product
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
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-2364-2017·2017-06-21
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-P605), REF 22325 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-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

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