Recall Z-0106-2023 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
| Date | Oct 20, 2022 (initiated Sep 7, 2022) |
| Status | Terminated |
| Reason | One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a Medical Device Recall note on 09/08/2022 by mail and email. The notice explained the problem and the potential hazard and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. 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 form. The |
| Quantity | 18 kits |
| Distribution | US Nationwide distribution in the states of CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.