Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Reason for recall: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. Quantity: 973,785 total units Lot/code info: 1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7331357 ; 3) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7266123 ; 4) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333452 ; 5) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333453 ; 6) SOT4FRUWFC, UDI-DI:10197106732304 (each) 50197106732302 (case), Lot Number: 7350031 ;
10197106526187, 50197106526185, 10197106627891, 50197106627899, 10197106732304, 50197106732302
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.