Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0633-2019·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error regarding chemical breakthrough times rather than a direct defect causing reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors.

Plain-English summary

Cardinal Health 200, LLC is recalling 1,475,095 pairs of Protexis Neoprene Surgical Gloves, Size 6.5. The recall is due to a labeling issue on the primary packaging (wallets) of the gloves.

The labels incorrectly state the breakthrough (permeation) times for two chemotherapy drugs, Carmustine and Thiotepa. Additionally, breakthrough times for Mitomycin were added to the label in error. The gloves are sterile, powder-free, and made of synthetic rubber, intended to be worn by operating room personnel to protect surgical wounds from contamination.

The affected gloves were distributed nationwide in the United States and in various countries including Austria, Belgium, Canada, and the United Kingdom. Healthcare facilities and consumers should stop using the affected gloves and contact Cardinal Health for instructions on return or replacement.

The recalled product

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.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Gloves
Hazard: mis-labeling
Affected units: 1,475,095

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

Product code: 2D73DP65
Lot Numbers: TS18050409
TS18060149
TS18060240
TS18060312
TS18070036
TS18070106
TS18070306
TS18070371
TS18080026
TS18080348
TS18080445
TS18090113
TS18090159
TS18090212
and TS18090282.

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · mis labeling