Z-2626-2023 Class II Ongoing

Recalled by O&M HALYARD, INC. — Mechanicsville, VA

Recall Details

Product Type
Devices
Report Date
September 27, 2023
Initiation Date
August 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41790 masks

Product Description

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 Pattern

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

Code Information

UDI-DI: 20680651468271; Lot Number AM2164811