FDAClass IIDecember 22, 2021

Cardinal Health Poly-Reinforced Surgical Gowns Large recall: Sterility Concern

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

Why was Cardinal Health Poly-Reinforced Surgical Gowns 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: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)

Product
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Recalling firm
Cardinal Health
Quantity
17,174 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)
Open FDA enforcement record Latest recalls