—#206446

Product

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

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Timeline

Recall initiated: 2024-02-23
Posted by FDA: 2024-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.