FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47
FDA device recall Z-1059-2023 · posted 2023-02-03 · Open, Classified
Recall details
- Recalling firm
- Owens & Minor Distribution, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- FXX
- Quantity affected
- 73 cases
- Distribution
- US distribution to IL, NC, NY, OH, and PA.
- Date initiated
- 2023-01-03
- Date posted
- 2023-02-03
- Location
- Mechanicsville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KC 300 SURGICAL MASK (K131879) | Kimberly-Clark Corp. | 2013-12-20 |