RoyalSilk Non-Reinforced Surgical Gowns XX-large recall: Sterility Concern
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Why was RoyalSilk Non-Reinforced Surgical Gowns XX-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: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
- Recalling firm
- Cardinal Health
- Quantity
- 9,990 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)