Recall Z-2915-2020— Cardinal Health 200, LLC

Name: FDA recall Z-2915-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-29

Class II · Completed

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-07-29. It names one FDA 510(k) clearance: K001924. Product: PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Completed
Initiated: 2020-07-29
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K001924 — COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0Allegiance Healthcare Corp.·cleared 2000-07-14

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

PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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.

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