Recall Z-0782-2021 ยท LRO General Surgery Tray
Medline Industries Inc
Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
| Date | Nov 13, 2020 |
| Status | Terminated |
| Reason | The cylindrical sponge component is not x-ray detectable. |
| Root cause | Process control |
| Action | Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected. |
| Quantity | 45 |
| Distribution | Foreign distribution only - Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.