Recall Z-1424-2025 ยท NWU Endoscope Introducer Kit
American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
| Date | Mar 21, 2025 (initiated Jan 31, 2025) |
| Status | Open, Classified |
| Reason | Sterility assurance with procedure trays |
| Root cause | Process change control |
| Action | On 1/31/25 customers were notified via. phone about the recall. On February 11, 2025, Owens & Minor, the parent company of American Contract System issued a "Urgent: Medical Device Recall" notification via email to affected customers. 1. DISCONTINUE USE of the procedure trays listed in Table 1 above. 2. RETURN PRODUCT: Contact your ACS Sales Representative for instructions on returning all product to ACS. 3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this recall and all unused product is r |
| Quantity | 800 |
| Distribution | US: AZ OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.