American Contract Systems, Inc. Recall 89868
Description: ACS Cath Lab Pack
American Contract Systems, Inc. Recall 89868 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1040-2022 |
| Event ID | 89868 |
| Event Description | ACS Cath Lab Pack |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IL, MO, NE, and TX. |
| Quantity | 10 packs |
| Recall Reason | Product was sterilized with a higher than specification EO concentration. |
| Device Classification | 20220518 |
| Device Code Info | Model FTCL83K, Lot 982221 UDI: 00191072151360 |
| Center Classification Date | 20220506 |
| Recall Initiation Date | 20220322 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | Letter |
| Similar To |