Recall Z-0317-2022— O&M HALYARD INC

Name: FDA recall Z-0317-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-27

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD INC, initiated 2021-09-27. It names one FDA 510(k) clearance: K182851. Product: HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL. Reason: All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing..

Recalling firm: O&M HALYARD INC
Classification: Class II
Status: Ongoing
Initiated: 2021-09-27
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K182851 — SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc.·cleared 2019-06-26

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

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

Reason for recall

All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

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