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

201–300 of 758

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-2566-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile intramedullary rod implants and accessories because packaging design verification tests failed.
Product
Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
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…
Category
Medical Device
Distribution
50 states
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-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-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 (Drugs)·D-0916-2017·2017-06-21
Pharmedium Recalls Vancomycin Injection Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 108 bags of Vancomycin HCl injection because the total volume was incorrectly printed on the label.
Product
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, 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 (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-2335-2017·2017-06-21
Arrow International Recalls Two-Lumen Central Venous Access Kits
Arrow International is recalling Two-Lumen Central Venous Access Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2348-2017·2017-06-21
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, leading to antibiotic degradation.
Product
VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2571-2017·2017-06-21
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 devices were distributed worldwide.
Product
Segmental fluted stem, 15x250mm 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-2368-2017·2017-06-21
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-P608), REF 22336, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2573-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile knee joint implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Segmental fluted stem, 17x250mm 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-2570-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Test Failures
Zimmer Biomet is recalling sterile knee implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
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…
Category
Drug
Distribution
6 states
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-2415-2017·2017-06-21
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-N245), REF 413394, 20 cards per carton.
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-2482-2017·2017-06-21
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-P638), IVD, REF 418423, 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-2502-2017·2017-06-21
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-P645), IVD, REF 419602, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2363-2017·2017-06-21
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-P603), REF 22320, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2596-2017·2017-06-21
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 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL…
Category
Medical Device
Distribution
50 states
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-2431-2017·2017-06-21
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-GN83), REF 413440, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2517-2017·2017-06-21
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-N354), IVD, REF 421350, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2462-2017·2017-06-21
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, leading to antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2558-2017·2017-06-21
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 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2504-2017·2017-06-21
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-N344), IVD, REF 420440, 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 (Devices)·Z-2352-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers may allow moisture to degrade antibiotic potency.
Product
VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2408-2017·2017-06-21
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-N235), REF 413170, 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-2440-2017·2017-06-21
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-N265), REF 413865, 20 cards per carton.
Category
Medical Device
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-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-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-2330-2017·2017-06-21
Arrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2473-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling 493 cartons of 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-N300), IVD, REF 416241, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2444-2017·2017-06-21
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-GN87), REF 413943, 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-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-2541-2017·2017-06-21
Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.
Product
Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"…
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-2550-2017·2017-06-21
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 9,867 units distributed worldwide.
Product
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2381-2017·2017-06-21
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-P621), REF 412533, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
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-2467-2017·2017-06-21
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-N292), REF 415063, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2562-2017·2017-06-21
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 specific lots distributed worldwide.
Product
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2466-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2450-2017·2017-06-21
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-N275), REF 414313, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2357-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.
Product
VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
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-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-2565-2017·2017-06-21
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 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2599-2017·2017-06-21
Zimmer Biomet Recalls Z Nail Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 1,707 sterile Z Nail implants because packaging design verification tests failed. The action covers domestic and foreign distribution.
Product
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
Category
Medical Device
Distribution
50 states
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-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-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-2538-2017·2017-06-21
Cook Inc. Recalls Endoscopic Introducer/Extractor Due to Inadequate Reprocessing Instructions
Cook Inc. is recalling 46 Endoscopic Introducer/Extractor devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Product
Endoscopic Introducer/Extractor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2355-2017·2017-06-21
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-P580), REF 22233, 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-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-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-2366-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 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-2509-2017·2017-06-21
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-P649), IVD, REF 420858, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2511-2017·2017-06-21
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-N350), IVD, REF 421037, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2460-2017·2017-06-21
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-GN92), IVD, REF 414963, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2469-2017·2017-06-21
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-GP75), IVD, REF 415670, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2429-2017·2017-06-21
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-GN81), REF 413438, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2383-2017·2017-06-21
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-N193), REF 412604, 20 cards per carton.
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-2411-2017·2017-06-21
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, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2441-2017·2017-06-21
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-N268), REF 413868, 20 cards per carton.
Category
Medical Device
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-2575-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2445-2017·2017-06-21
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-XN06), REF 413944, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2398-2017·2017-06-21
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-N216), REF 413066, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
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 (Devices)·Z-2422-2017·2017-06-21
Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall for Moisture Exposure
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-GN73), REF 413404, 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-2412-2017·2017-06-21
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-XN05), REF 413230, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2417-2017·2017-06-21
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-GN66), REF 413398, 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-2358-2017·2017-06-21
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-P586), REF 22276, 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-2343-2017·2017-06-21
Biomerieux Recalls VITEK 2 Yeast Identification Cards Due to Container Integrity Issues
Biomerieux Inc is recalling VITEK 2 Yeast identification cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2354-2017·2017-06-21
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-GP68), REF 22231, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2472-2017·2017-06-21
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-N298), IVD, REF 416004, 20 cards per carton.
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-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-2491-2017·2017-06-21
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-P642), IVD, REF 418604, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2600-2017·2017-06-21
Zimmer Biomet Recalls Sterile Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
Product
4.5 BROAD SCP PLT 26-H STER
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2525-2017·2017-06-21
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-N364), IVD, REF 421693, 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-2553-2017·2017-06-21
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 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
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-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-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

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