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

Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

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) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;

UPC codes

10195594353926, 50195594353924, 10195594439880, 50195594439888

Source

Official record: FDA (Device enforcement)

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

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