Recall Z-0992-2025 ยท LRP Tray, Surgical
MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
| Date | Jan 29, 2025 (initiated Dec 31, 2024) |
| Status | Open, Classified |
| Reason | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. |
| Root cause | Process design |
| Action | A MEDICAL DEVICE RECALL notification letter dated 12/31/24 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Upon receipt of your submitted response form, you |
| Quantity | 58 kits |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.