FDA (Devices) recall action 86131

Cardinal Health 200, LLC recalled 8 products on 2020-09-09

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2020-09-09
Critical: 0
Units: 56,957,000

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - 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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - 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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes or tears at the cuffs, compromising barrier protection.
Product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - 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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
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 sensiti
Category
Distribution
0 states
ModerateFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes or tears at the cuffs.
Product
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 sensiti
Category
Distribution
0 states
HighFDA (Devices)··2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - 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 sensiti
Category
Distribution
0 states