FDAClass IIDecember 22, 2021

Cardinal Health Poly-Reinforced Surgical Gowns XX-large recall: Sterility Concern

Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070

Why was Cardinal Health Poly-Reinforced Surgical Gowns XX-large recalled?

Potential for open packaging seals compromising the sterility of the surgical gowns

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot Numbers: 21CKQ001 21CKQ002 21HKQ001. UDI: 50192253005941 (cs) 10192253005943 (ea)

Product
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Recalling firm
Cardinal Health
Quantity
29,893 units
Distribution
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Recall date
December 22, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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