Z-0369-2022Class II

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Name: Z-0369-2022 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Creator: Cardinal Health
Published: 2021-11-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-11-02 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health began a recall of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 on 2021-11-02. FDA classified it as Class II and gives the reason as "Potential for open packaging seals compromising the sterility of the surgical gowns". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0369-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-02
Posted: 2021-12-10
Recalling firm: Medtronic, Inc.
Product: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Product code: FYA Gown, Surgical
Reason for recall: Potential for open packaging seals compromising the sterility of the surgical gowns
Root cause tag: manufacturing process
FDA 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 [email protected], 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: [email protected] 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0369-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0368-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0369-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0370-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0371-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0372-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0373-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0374-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0375-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0376-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0377-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0378-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10

Product code FYA

K023167Class IIBreathable Surgical GownAllegiance Healthcare Corp. / cleared 2002-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)