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.
What this means for you
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
- 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
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.
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