FDA Medical Device Recalls (openFDA)
Owens & Minor Distribution, Inc.: FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- Recall number
- Z-1059-2023
- Recalling firm
- Owens & Minor Distribution, Inc.
- Product
- FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- Status
- Open, Classified
- Initiated
- 2023-01-03
- Posted
- 2023-02-03
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling Change Control
- Action
- 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 @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-012 in the header of the response.
- Quantity
- 73 cases
- Distribution
- US distribution to IL, NC, NY, OH, and PA.
- Lot, serial or model codes
- UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
- 510(k) numbers
- ["K131879"]
- PMA numbers
- not on file
- Product code
- FXX
- 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