RoyalSilk Non-Reinforced Surgical Gowns XXX-large recall: Sterility Concern
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Why was RoyalSilk Non-Reinforced Surgical Gowns XXX-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: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
- Recalling firm
- Cardinal Health
- Quantity
- 8,950 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)