FDA recall Z-1059-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-01-03

Report date

2023-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mechanicsville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2023