RoyalSilk Non-Reinforced Surgical Gowns Large recall: Sterility Concern
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Why was RoyalSilk Non-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: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
- Product
- RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
- Recalling firm
- Cardinal Health
- Quantity
- 364,481 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)