PlainRecalls
FDA Devices Moderate Class II Completed

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - 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.

Reported: September 9, 2020 Initiated: July 29, 2020 #Z-2916-2020

Product Description

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - 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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
7119625 total
Distribution
US Nationwide distribution
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - 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.. Recalled by Cardinal Health 200, LLC. Units affected: 7119625 total.
Why was this product recalled?
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2916-2020.