Recall Z-1443-2024 ยท LRP Tray, Surgical
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
| 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 | 1335 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.