FDA (Devices) recall action 81579

Cardinal Health 200, LLC recalled 8 products on 2018-12-26

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: 2018-12-26
Critical: 0
Units: 11,800,760

Why these products were recalled

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

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.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging lists incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states
ModerateFDA (Devices)··2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Distribution
50 states