Recall Z-2522-2024 ยท OJK Eye Tray
American Contract Systems, Inc.
American Contract Systems Cataract Pack convenience kit
| Date | Aug 7, 2024 (initiated May 6, 2024) |
| Status | Open, Classified |
| Reason | Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible. |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.