MEDLINE INDUSTRIES, LP - Northfield: Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTR

Hazard

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.

Details from the source

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. Quantity: 7950 units Lot/code info: a) 66580, UDI/DI 10653160028963 (case) 00653160028966 (each), Lot Numbers: 2023041090; b) I86630, UDI/DI 00653160286540 (case) 10653160286547 (each), Lot Numbers: 2023101190; c) I86690, UDI/DI 00653160290752 (case) 10653160290759 (each), Lot Numbers: 2023103190; d) I86815, UDI/DI 00653160342291 (case) 10653160342298 (each), Lot Numbers: 2023112190; e) MNS12675, UDI/DI 00653160337341 (case) 10653160337348 (each), Lot Numbers: 2023070390; f) SUT20350, UDI/DI 00653160306552 (case) 10653160306559 (each), Lot Numbers: 2023022290, 2023041190, 2023042490, 2023052390, 2023101890 MEDLINE: UDI/DI 20193489191582 (case) 10193489191585 (each), Lot Numbers: 2023062290, 2023081490

UPC codes

10653160028963, 00653160028966, 00653160286540, 10653160286547, 00653160290752, 10653160290759, 00653160342291, 10653160342298, 00653160337341, 10653160337348, 00653160306552, 10653160306559, 20193489191582, 10193489191585

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.