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FDA (Device enforcement)Recalled 2024-11-08class ii

Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;

Hazard

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Details from the source

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) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J4219A ; 2) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J4678M ; 3) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J53W13 ; 4) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6277W ; 5) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J7904P ; 6) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J8491U ; 7) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6785Z ; 8) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6786D ; 9) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J9602P ; 10) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J96A00 ; 11) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J96N37 ; 12) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: 5136008 ; 13) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: 5405613 ; 14) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: PO351726 ;

UPC codes

10885425517206, 50885425517204

Source

Official record: FDA (Device enforcement)

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

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