American Contract Systems, Inc. Recall 90574
Description: Various ob/gyn packs
American Contract Systems, Inc. Recall 90574 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1701-2022 |
| Event ID | 90574 |
| Event Description | Various ob/gyn packs |
| Product Type | Devices |
| Distribution | Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX |
| Quantity | 15 units |
| Recall Reason | Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| Device Classification | 20220914 |
| Device Code Info | Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSROBDELIVC, 2104091, 904211, 14531604 2) LSRVAGDELIVC, 2106011, 863211, 44252284 3) LSRVAGDELIVC, 2106011, 863211, 44135283 4) LSRCFHVAGDC, 2108042, 791211, 64123598 5) LSRCFHVAGDC, 2108042, 791211, 64123599 6) LSRCFHVAGDC, 2108042, 791211, 64123597 7) LSRVAGDELIVC, 2108181, 776211, 44139780 8) LSROBDELIVC, 2109231, 743211, 64319309 9) UPVD01G, 2109211, 741211, 15187693 10) MEVG08P, 2105132, 873211, 14874335-004 11) SLOB77F, 2108101, 779211, 15093748-004 12) MEVG08Q, 2108192, 770211, 15103947-004 13) BHVG89C, 2104291, 887211, 14962314-004 14) BHVG89C, 2106303, 827211, 14956518-004 15) AGOB35D, 2107221, 799211, 64183198-006 |
| Center Classification Date | 20220908 |
| Recall Initiation Date | 20220616 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | |
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