Recall Z-0558-2025 ยท FDE Laparoscopy Kit
MEDLINE INDUSTRIES, LP - Northfield
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
| Date | Nov 26, 2024 (initiated Oct 25, 2024) |
| Status | Open, Classified |
| Reason | Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component. |
| Root cause | Labeling Change Control |
| Action | On October 25, 2024, the firm notified customers of the recall via letters titled "Olympus America, Inc. IMMEDIATE ACTION REQUIRED RECALL". Customers were informed that the specified lot of kits may contain the affected lot of Single Use Biopsy Valve MAJ-1555 recalled by Olympus. The missing sterile and manufacturing lot numbers and expiration dates can be found on the outer box or zipper bag label. Affected product should not be used if you are unable to determine the expiration date. Customers should locate and quarantine all product from affected lot. Customers should complete the response |
| Quantity | 100 |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.