Medical device recalls

Owens & Minor Distribution, Inc. recalls FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 4…

Recall date
January 3, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1059-2023
FDA classification
Class III
Brand / firm
Owens & Minor Distribution, Inc.
Sold / distributed
US distribution to IL, NC, NY, OH, and PA.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

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