The Recall Desk
ModerateFDA (Devices)·Z-0638-2019·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 primary packaging contains 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 without reporting any illnesses or injuries. This aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Cardinal Health 200, LLC is recalling 1,475,095 pairs of Protexis Neoprene Surgical Gloves, Size 9.0. The recall is due to a labeling issue on the primary packaging (wallet) of the gloves. 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.

The affected product is a powder-free, sterile, light brown disposable surgical glove made of synthetic rubber. It is intended to be worn by operating room personnel to protect surgical wounds from contamination. The specific product code is 2D73DP90, and the affected lot numbers are TS18060016, TS18070126, TS18070315, TS18080353, and TS18090220.

The product was distributed nationwide in the United States and in 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 consumers should check their inventory for these specific lot numbers and stop using the product if the packaging matches the description.

The recalled product

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.
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: 2D73DP90
  • Lot Numbers: TS18060016
  • TS18070126
  • TS18070315
  • TS18080353
  • and TS18090220.

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 →