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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSleeve PolyReinforced Breathable Sleeve Surgical Gowns

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  Class 2 Device Recall SmartSleeve PolyReinforced Breathable Sleeve Surgical Gowns see related information
Date Initiated by Firm November 02, 2021
Create Date December 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-0369-2022
Recall Event ID 89015
510(K)Number K023167  
Product Classification Gown, surgical - Product Code FYA
Product SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large
SKU: 9011
Code Information Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)
Recalling Firm/
Manufacturer		 Cardinal Health
1270 Waukegan Rd Bldg C
Waukegan IL 60085-6722
For Additional Information Contact SAME
847-578-6610
Manufacturer Reason
for Recall		 Potential for open packaging seals compromising the sterility of the surgical gowns
FDA Determined
Cause 2		 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 in Commerce 169,262 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = ALLEGIANCE HEALTHCARE CORP.
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