FDA recall Z-2626-2023

O&M HALYARD, INC. · Class II · device

Product

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

Reason for recall

One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

Distribution

US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia

Key facts

Status
Ongoing
Initiation date
2023-08-09
Report date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mechanicsville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2626-2023