Cardinal Health recalls Protexis Neoprene surgical gloves size 9.0 due to incorrect labeling of chemotherapy drug breakthrough times. This may affect operating room use. Check product codes and lot numbers for affected items.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
Cardinal Health is recalling Protexis Neoprene surgical gloves size 9.0 because the labeling for chemotherapy drug breakthrough times is incorrect. This could lead to improper assessment of glove protection during surgery, potentially affecting patient safety.
The gloves' labeling incorrectly states the time it takes for chemotherapy drugs to penetrate the gloves. This could mean the gloves provide less protection than intended, especially for drugs like Carmustine and Thiotepa. The error also includes incorrect information about Mitomycin breakthrough times.
Operating room personnel who use the Protexis Neoprene surgical gloves size 9.0 are likely affected. Those handling chemotherapy drugs during surgery are at the highest risk due to the potential for incorrect breakthrough times.
Check for product code 2D73DP90 and lot numbers TS18060016, TS18070126, TS18070315, TS18080353, or TS18090220. The gloves are powder-free, light brown, and intended for surgical use.
Verify the product code and lot numbers to confirm if your gloves are affected.
The labeling for chemotherapy drug breakthrough times is incorrect, which could affect how well the gloves protect against these drugs during surgery.
The incorrect labeling includes breakthrough times for Carmustine, Thiotepa, and Mitomycin.
Check for product code 2D73DP90 and lot numbers TS18060016, TS18070126, TS18070315, TS18080353, or TS18090220.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0638-2019 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0638-2019 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
