Recall Z-1449-2024 ยท JOK Scissors, Medical, Disposable
MEDLINE INDUSTRIES, LP - Northfield
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670
| 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 | 84224 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.