RoyalSilk Non-Reinforced Surgical Gowns X-large recall: Sterility Concern
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Why was RoyalSilk Non-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: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
- Product
- RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
- Recalling firm
- Cardinal Health
- Quantity
- 270,839 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)