Z-2626-2023 Class II Ongoing
FDA device recall Z-2626-2023 was initiated by O&M HALYARD, INC. on August 9, 2023 and is designated Class II. Reason for recall: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. The recall status is ongoing. Affected quantity: 41790 masks.
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