Recall Z-1995-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
| Date | Jun 20, 2025 (initiated May 15, 2025) |
| Status | Open, Classified |
| Reason | There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE PRODUCT RECALL notification letter dated 5/15/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 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 resp |
| Quantity | 174 units |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.