Aero Blue Performance Surgical Gown, XL- Sterile surgical… recallZ-0343-2023 · Owens & Minor Distribution, Inc. · initiated Oct 31, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Owens & Minor Distribution, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0343-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2022
- Posted by the FDA
- Dec 6, 2022
- Recalling firm
- Owens & Minor Distribution, Inc.
- Quantity
- 72 cases (2160 pouches)
- Product code
- FYA
- FDA submissions
- K192362
- Distribution
- IL, IN, WV
Product description
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Code information (models, lots, serial numbers)
UDI-DI: 10680651417340 Lot Number: AH1215T51
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 41734O&M Halyard, Inc. · GOWN, SURGICAL1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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