FDA recall Z-2913-2020

Cardinal Health 200, LLC · Class II · device

Product

PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Reason for recall

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Distribution

US Nationwide distribution

Key facts

Status
Completed
Initiation date
2020-07-29
Report date
2020-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2913-2020