Recall Z-1038-2022 ยท OIP Radiology-Diagnostic Kit
American Contract Systems, Inc.
ACS IR - Angio Pack
| Date | Mar 22, 2022 |
| Status | Open, Classified |
| Reason | Product was sterilized with a higher than specification EO concentration. |
| Root cause | Process control |
| Action | A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to suzanne.thomas@hyh.com, even if you do not have product inventory. |
| Quantity | 24 packs |
| Distribution | US Nationwide distribution in the states of IL, MO, NE, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.