FDA-Device2023-02-15Class III
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Owens & Minor Distribution, Inc.
Hazard
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.
Sold states
US distribution to IL, NC, NY, OH, and PA.
Affected count
73 cases
Manufactured in
9120 Lockwood Blvd, Mechanicsville, VA, United States
Products
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2023Don't want to check this manually?
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