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Recall Observatory FDA recall evidence

Device product

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

Z-1131-2025

November 08, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 95947
Status
Ongoing
Classification
Class II
Quantity
973,785 total units
Official record key
device-enforcement:Z-1131-2025

Official wording

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

Code information: 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 ;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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