The Recall Desk

Archive

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

201–300 of 758

  • 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 Fl
    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-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-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-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 (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-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-2329-2017·2017-06-21

    Arrow International Recalls Introducer Kits Due to Potential Sterility Compromise

    Arrow International is recalling Introducer Kits and Arrow PSI Kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-2447-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Container Integrity Issues

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2400-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-2373-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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 (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 (Drugs)·D-0914-2017·2017-06-21

    Pharmedium Recalls Vancomycin Bags With Incorrect Volume Labeling

    Pharmedium Services is recalling 816 bags of Vancomycin HCl injection because the total volume was incorrectly labeled as 500 mL instead of 300 mL.

    Product
    VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, 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-2522-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-2490-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures

    Zimmer Biomet is recalling sterile hip implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.

    Product
    Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2423-2017·2017-06-21

    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.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN84), REF 413410, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2418-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2514-2017·2017-06-21

    Biomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2470-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-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-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-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-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-2392-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2485-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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 (Devices)·Z-2396-2017·2017-06-21

    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 degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2549-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories due to packaging design verification test failures.

    Product
    Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0908-2017·2017-06-21

    Pharmedium Recalls Potassium Phosphate Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 144 bags of Potassium Phosphate in 0.5% Dextrose because the product label incorrectly states a volume of 150 mL instead of the actual 100 mL.

    Product
    Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-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-2461-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Fungal Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-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 (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-2551-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories due to packaging design verification test failures.

    Product
    Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2488-2017·2017-06-21

    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-P641), IVD, REF 418590, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2578-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling 9,867 sterile porous femoral stems because packaging design verification tests failed. The recall covers units distributed worldwide.

    Product
    Por fullct fem st 16x200mm, Sterile,
    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-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-2572-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures

    Zimmer Biomet is recalling 9,867 sterile knee implants because packaging design verification tests failed. The recall covers units distributed worldwide.

    Product
    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2433-2017·2017-06-21

    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-N250), REF 413573, 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 (Drugs)·D-0901-2017·2017-06-21

    Safecor Health Recalls Atorvastatin Calcium 40mg Tablets Due to CGMP Deviations

    Safecor Health is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
    Category
    Drug
    Distribution
    2 states
  • 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 (Devices)·Z-2584-2017·2017-06-21

    Acumedia Recalls Palcam Supplement Due to Possible Bacillus Contamination

    Acumedia Manufacturers, Inc. is recalling Palcam Supplement (PN 7987) due to possible contamination with Bacillus spp. The product is used for Listeria enrichment.

    Product
    Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2380-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2586-2017·2017-06-21

    Medtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent

    Medtest Holdings is recalling specific lots of Pointe Scientific Hitachi Total Bilirubin R1 Reagent due to decreased reactivity of the R1 component.

    Product
    Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-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 (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-2594-2017·2017-06-21

    Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures

    Zimmer Biomet is recalling 510 units of sterile-packaged VERSA-FX II STD TUBE implants because packaging design verification tests failed.

    Product
    VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-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-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-2561-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Tibial Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.

    Product
    Tibial IM Nail 15mmdx44cm, 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-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-2401-2017·2017-06-21

    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-N223), REF 413110, 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-2455-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories because packaging design verification tests failed. The action covers 9,867 units distributed worldwide.

    Product
    Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2017·2017-06-21

    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 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2342-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram-Positive Identification Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram-Positive identification cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2439-2017·2017-06-21

    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-N264), REF 413864, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2503-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-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-2427-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-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-2593-2017·2017-06-21

    Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures

    Zimmer Biomet is recalling 445 units of sterile-packaged VERSA-FXII SC TUBE PLT implants due to packaging design verification test failures.

    Product
    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-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-2424-2017·2017-06-21

    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-GN75), REF 413432, 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-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 (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

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