FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- Company
- Owens & Minor Distribution, Inc.
- Recall Initiated
- January 3, 2023
- Posted
- February 3, 2023
- Recall Number
- Z-1059-2023
- Quantity
- 73 cases
- Firm Location
- Mechanicsville, VA
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.
Distribution
US distribution to IL, NC, NY, OH, and PA.
Lot / Code Info
UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Root Cause
Labeling Change Control
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.