Recall Z-1445-2024 ยท MCZ Suture Removal Kit
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
| Date | Mar 29, 2024 (initiated Feb 23, 2024) |
| Status | Open, Classified |
| Reason | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| Root cause | Process control |
| Action | Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers. |
| Quantity | 23,290 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Panama, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.