Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceArrow International IncClass IIArrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
- 2017-06-21FDA-DeviceArrow International IncClass IIARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
- 2017-06-21FDA-DeviceArrow International IncClass IIArrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
- 2017-06-21FDA-DeviceArrow International IncClass IIArrow 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
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass II1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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