Recall

All recalls7,799 total

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

D
DEPUY (IRELAND) — Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

B
B
B
B
D
DFI Co., Ltd. — One Step pH in vitro diagnostic test REF: 31I4P

The devices were distributed without required FDA premarket clearance or approval.

D
DFI Co., Ltd. — One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

D
DFI Co., Ltd. — Uric Acid in vitro diagnostic test REF: 31H0P

The devices were distributed without required FDA premarket clearance or approval.

W
Windstone Medical Packaging, Inc. — Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

D
DFI Co., Ltd. — QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

The devices were distributed without required FDA premarket clearance or approval.

D
DFI Co., Ltd. — One Step P in vitro diagnostic test REF: 8194

The devices were distributed without required FDA premarket clearance or approval.

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