Recall Z-1359-2025 ยท OEZ Cardiovascular Procedure Kit
American Contract Systems Inc
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
| Date | Mar 14, 2025 (initiated Feb 6, 2025) |
| Status | Open, Classified |
| Reason | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Root cause | Process control |
| Action | The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded. |
| Quantity | 54 kits |
| Distribution | US Nationwide distribution in the state of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.