FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Recall
- Recall Number
- Z-1059-2023
- Event Number
- 91530
- Firm
- Owens & Minor Distribution, Inc.
- FEI Number
- 3003753847
- Product Code
- FXX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- January 3, 2023
- Posted
- February 3, 2023
- Address
- 9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015
Description
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
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.
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.
US distribution to IL, NC, NY, OH, and PA.
73 cases