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Recall Observatory FDA recall evidence

Device product

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Z-0902-2022

March 15, 2022

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 89832
Status
Completed
Classification
Class II
Quantity
486,578 pairs
Official record key
device-enforcement:Z-0902-2022

Official wording

Reason: Product was distributed without being sterilized.

Code information: Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939

Distribution pattern: Product distributed throughout United States and Guam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was distributed without being sterilized.