American Contract Systems, Inc. Recall 96321
Description: Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
American Contract Systems, Inc. Recall 96321 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1426-2025 |
| Event ID | 96321 |
| Event Description | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No |
| Product Type | Devices |
| Distribution | US: AZ OUS: None |
| Quantity | 460 kits. |
| Recall Reason | Sterility assurance with procedure trays |
| Device Classification | 20250402 |
| Device Code Info | Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026 |
| Center Classification Date | 20250321 |
| Recall Initiation Date | 20250131 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | Letter |
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