Z-0343-2023Class II

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

Name: Z-0343-2023 Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Creator: Owens & Minor Distribution, Inc.
Published: 2022-10-31
License: https://open.fda.gov/license/

Owens & Minor Distribution, Inc. / initiated 2022-10-31 / Open, Classified / root cause: packaging

FDA source

Owens & Minor Distribution, Inc. began a recall of Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 on 2022-10-31. FDA classified it as Class II and gives the reason as "Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0343-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-31
Posted: 2022-12-06
Recalling firm: Owens & Minor Distribution, Inc.
Product: Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Product code: FYA Gown, Surgical
Reason for recall: Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Owens & Minor initiated recall by Voluntary Recall - EVENT # FCA-2022-009 letter dated 10/31/22 via email and Overnight mail. Letter states reason for recall, health risk and action to take: 1. REVIEW your inventory for the affected products. 2. SEGREGATE AND QUARANTINE all product on-hand per the Affected Product table above. 3. DESTROY or DISCARD the product per the facility s standard disposal procedure for surgical gowns. 4. COMMUNICATE this recall to staff to ensure awareness of the product issue. If the affected product identified above was further distributed, please ensure all end-users are appropriately notified of this recall notification. 5. RETURN the completed Recall Response Form and Certificate of Destruction Form to [email protected] as soon as possible even if you have no current product inventory. If you have any questions, please email Caitlin Senter @ [email protected] using the Event # FCA-2022-009 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.
Quantity in commerce: 72 cases (2160 pouches)
Distribution: IL, IN, WV
Product codes and lots: UDI-DI: 10680651417340 Lot Number: AH1215T51

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0343-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0343-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code FYA

K192362Class IIAero Blue Performance Surgical GownsO&M Halyard, Inc. / cleared 2019-12-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)