Recall Z-2133-2023 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
| Date | Jul 12, 2023 (initiated May 18, 2023) |
| Status | Open, Classified |
| Reason | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". |
| Root cause | Process control |
| Action | Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline. |
| Quantity | 144 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.