FDA Medical Device Recalls (openFDA)
Cardinal Health: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Recall number
- Z-0370-2022
- Recalling firm
- Cardinal Health
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Status
- Open, Classified
- Initiated
- 2021-11-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Root cause
- Process control
- Action
- Cardinal Health issued Urgent Medical Device Recall Letter dated November 2, 2021, stating reason for recall, health risk and action to take: 1) REVIEW your inventory for affected product. 2) SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Attachment 1. 3) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 4) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. 5) CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other Customers 888-444-5440 6) CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Available Assistance: Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other customers 888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Quantity
- 231,219 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.
- Lot, serial or model codes
- Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea)
- 510(k) numbers
- ["K023167"]
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 1416549
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28