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.
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 without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health 200, LLC is recalling 1,475,095 pairs of Protexis Neoprene Surgical Gloves, Size 8.5. The recall is due to a labeling issue where the breakthrough times for two chemotherapy drugs, Carmustine and Thiotepa, stated on the primary packaging are incorrect. Additionally, breakthrough times for Mitomycin were added to the label in error.
The affected gloves are powder-free, sterile, light brown, disposable devices made of synthetic rubber intended for operating room personnel to protect surgical wounds from contamination. The specific product code is 2D73DP85, and the affected lot numbers are TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.
The product was distributed nationwide in the United States and in several countries including Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected gloves.
The recalled product
- 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.
- 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 (8)
- Product code: 2D73DP85
- Lot Numbers: TS18060015
- TS18060329
- TS18070121
- TS18070314
- TS18080034
- TS18080352
- and TS18090219.
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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