Recall Z-2626-2023— O&M HALYARD, INC.

Name: FDA recall Z-2626-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-09

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD, INC., initiated 2023-08-09. It names one FDA 510(k) clearance: K974068. Product: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827. Reason: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user..

Recalling firm: O&M HALYARD, INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-09
Firm location: Mechanicsville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALTecnol Medical Products, Inc.·cleared 1997-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.