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Recall Observatory FDA recall evidence

Device product

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

Z-2626-2023

August 09, 2023

Class II

Product summary

Firm
O&M HALYARD, INC.
Event
Event 92942
Status
Ongoing
Classification
Class II
Quantity
41790 masks
Official record key
device-enforcement:Z-2626-2023

Official wording

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

Code information: UDI-DI: 20680651468271; Lot Number AM2164811

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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