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.
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. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination where no harm has been reported.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling approximately 1,475,095 pairs of Protexis Neoprene Surgical Gloves, Size 5.5. These are powder-free, sterile, light brown disposable surgical gloves made of synthetic rubber, intended for use by operating room personnel to protect surgical wounds from contamination.
The recall is due to a labeling issue on the primary packaging (wallet). The breakthrough times listed for two chemotherapy drugs, Carmustine and Thiotepa, are incorrect. Additionally, breakthrough times for Mitomycin were added to the label in error. This mislabeling could affect the safety of healthcare workers and patients if the gloves are used with these specific agents based on the incorrect data.
The affected product is identified by product code 2D73DP55 and lot numbers TS18060249, TS18070244, TS18080021, TS18080344, and TS18090280. The gloves were distributed nationwide in the United States and to several international 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 distributors should stop using the affected gloves and contact Cardinal Health for instructions on return or disposal.
The recalled product
- 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.
- 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 (6)
- Product code: 2D73DP55
- Lot Numbers: TS18060249
- TS18070244
- TS18080021
- TS18080344
- and TS18090280.
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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