Recall of BD ChloraPrep Clear 2% CHG and 70% IPA preoperative skin prep due to potential open seal on packaging, risking contamination.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
BD ChloraPrep Clear preoperative skin preparation solution is recalled because the packaging may have an open seal, which could lead to contamination. This affects patients undergoing surgery who use the product.
The product may have an open seal on the packaging, which could allow contamination. This is a lack of assurance of sterility, meaning the solution might not be sterile when used.
Patients scheduled for surgery who use this preoperative skin prep solution are affected. Those with the specific lot numbers are at risk of contamination if the packaging seal is compromised.
Check for the product name 'BD ChloraPrep Clear', lot numbers 3354127 or 3350974, and expiration date 12/31/2026 on the packaging.
Inspect the packaging for an open seal; if present, do not use the product.
The product may not be sterile if the packaging has an open seal, so it should not be used if the seal is compromised.
Check the packaging for an open seal; if found, do not use it. Contact BD for further instructions.
Look for lot numbers 3354127 or 3350974 with expiration date 12/31/2026 on the packaging.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall D-0441-2025 — BD BD Hello, I own a BD that is covered by recall D-0441-2025 from BD. 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.
