FDAClass IIDecember 22, 2021

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

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

Why was Cardinal Health Poly-Reinforced Surgical Gowns X-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: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)

Product
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Recalling firm
Cardinal Health
Quantity
146,939 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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