Recall Z-0350-2025 ยท OJH Orthopedic Tray
MEDLINE INDUSTRIES, LP - Northfield
ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
| Date | Nov 8, 2024 (initiated Oct 4, 2024) |
| Status | Open, Classified |
| Reason | Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer. 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, your account |
| Quantity | 80 units |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.