FDA recall Z-0317-2022

O&M HALYARD INC · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of EU/Canada.

Key facts

Status
Ongoing
Initiation date
2021-09-27
Report date
2021-12-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0317-2022