FDAClass IIApril 20, 2022

Cardinal Health PROTEXIS PI and PI Classic recall

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Why was Cardinal Health PROTEXIS PI and PI Classic recalled?

Product was distributed without being sterilized.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Recalling firm
Cardinal Health 200, LLC
Quantity
486,578 pairs
Distribution
Product distributed throughout United States and Guam
Recall date
April 20, 2022
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls