FDA recall Z-0838-2022

Ansell Healthcare Products LLC · Class II · device

Product

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Reason for recall

Transport company failed to stop at the border for required FDA inspection.

Distribution

U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

Key facts

Status
Ongoing
Initiation date
2022-02-19
Report date
2022-04-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0838-2022