FDA Medical Device Recalls (openFDA)
Owens & Minor Distribution, Inc.: Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Recall number
- Z-0343-2023
- Recalling firm
- Owens & Minor Distribution, Inc.
- Product
- Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Status
- Open, Classified
- Initiated
- 2022-10-31
- Posted
- 2022-12-06
- Terminated
- not on file
- Reason
- Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
- 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 OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please email Caitlin Senter @ OMRA_RECALLS@owens-minor.com 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
- 72 cases (2160 pouches)
- Distribution
- IL, IN, WV
- Lot, serial or model codes
- UDI-DI: 10680651417340 Lot Number: AH1215T51
- 510(k) numbers
- ["K192362"]
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 3003753847
- Firm city
- Mechanicsville
- Firm state
- VA
- 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