Cardinal Health recalls Protexis Neoprene Surgical Gloves Size 6.5 due to incorrect labeling of chemotherapy drug breakthrough times. This affects specific lot numbers and may lead to improper infection control during surgery.
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 6.5 because the label incorrectly states the time it takes for chemotherapy drugs to penetrate the gloves. This could mean surgeons are not properly protected from contamination during procedures.
The gloves are labeled with incorrect breakthrough times for chemotherapy drugs like Carmustine and Thiotepa. If the actual time for these drugs to penetrate the gloves is longer than stated, the gloves may not provide adequate protection during surgery, increasing the risk of contamination.
Operating room personnel who use the recalled gloves are affected. Surgeons and medical staff handling chemotherapy patients are most at risk due to potential contamination.
Check for the product code 2D73DP65 and lot numbers listed in the recall notice. The gloves are sterile light brown, powder-free, and size 6.5.
Verify the product code (2D73DP65) and lot numbers (TS18050409 to TS18090282) to confirm if your gloves are affected.
The label incorrectly states the breakthrough times for chemotherapy drugs like Carmustine and Thiotepa, which could lead to inadequate protection during surgery.
No, but you should check the product code and lot numbers to confirm if your gloves are affected before using them.
Check the product code and lot numbers to see if your gloves are affected; if they are, you do not need to discard them immediately but should verify with the recall notice.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0633-2019 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0633-2019 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.