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
This recall is currently active, issued March 29, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 23, 2024
- Posted
- March 29, 2024
- Recall Number
- Z-1443-2024
- Quantity
- 1335 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Lot / Code Info
a) I68905, UDI/DI 00653160350944 (case) 10653160350941 (each), Lot Numbers: 2023012590, 2023042590; b) MNS11505, UDI/DI 00653160320213 (case) 10653160320210 (each), Lot Numbers: 2023022490, 2023071390; c) MNS11545, UDI/DI 00653160320305 (case) 10653160320302 (each), Lot Numbers: 2023021390; d) SUT21355, UDI/DI 00653160329223 (case) 10653160329220 (each), Lot Numbers: 2023060790
Root Cause
Process control
Action Taken
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.