Recall Z-0513-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
| Date | Nov 22, 2024 (initiated Oct 16, 2024) |
| Status | Open, Classified |
| Reason | The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
| Root cause | Under Investigation by firm |
| Action | An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 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 |
| Quantity | 3744 units |
| Distribution | US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.