SmartGown Breathable Surgical Gowns with raglan sleeves recall: Sterility Concern
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Why was SmartGown Breathable Surgical Gowns with raglan sleeves 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: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
- Product
- SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
- Recalling firm
- Cardinal Health
- Quantity
- 224,312 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)