FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining… recallZ-1059-2023 · Owens & Minor Distribution, Inc. · initiated Jan 3, 2023
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
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
FDA root cause category: Labeling Change Control
What the company is doing
On January 3, 2023, the firm notified affected distributors via email with a "VOLUNTARY FIELD CORRECTION" letter. Consignees are instructed to immediately stop use of the product, quarantine any stock and destroy all the product using the facility s standard disposal procedure. Consignees are requested to complete and return a Recall FIELD CORRECTION RESPONSE FORM and a Certificate of Destruction. If you have any questions, please email Anu Singh @ [email protected] using the Event # FCA-2022-012 in the header of the response.
Recall details
- Recall number
- Z-1059-2023
- Status
- Open, Classified
- Initiated by the company
- Jan 3, 2023
- Posted by the FDA
- Feb 3, 2023
- Recalling firm
- Owens & Minor Distribution, Inc.
- Quantity
- 73 cases
- Product code
- FXX
- FDA submissions
- K131879
- Distribution
- US distribution to IL, NC, NY, OH, and PA.
Product description
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Code information (models, lots, serial numbers)
UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
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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