Recall Z-1059-2023
Owens & Minor Distribution, Inc. · initiated January 3, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Codes / lots: UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
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.
FDA-determined 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.
Details
- Recall number
- Z-1059-2023
- Initiated
- January 3, 2023
- Posted by FDA
- February 3, 2023
- Product code
- FXX – Mask, Surgical
- Quantity
- 73 cases
- Distribution
- US distribution to IL, NC, NY, OH, and PA.
- Recalling firm
- Owens & Minor Distribution, Inc., Mechanicsville, VA