BD recalls PurPrep 50x26mL iodine-alcohol solution due to unsterilized applicators. Products distributed outside intended channels risk infection.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
BD is recalling PurPrep 50x26mL iodine-alcohol solutions because the applicators were distributed without proper sterilization. This could lead to infections if used without being sterilized first.
The applicators were intended for further sterilization but were distributed directly to customers. This means they may not be sterile when used, increasing infection risk during medical procedures.
Users of the PurPrep solution for medical procedures who received it outside the intended distribution channel. Healthcare professionals and patients using the product without proper sterilization are at risk.
Check for the product name 'BD PurPrep', 50x26mL, with NDC 54365-014-42 or lot number 4298581. Products sold by CareFusion 213, LLC in El Paso, TX.
Verify the NDC number 54365-014-42 or lot number 4298581 on the packaging.
The product was distributed without proper sterilization, so it may not be safe for medical use without additional sterilization steps.
Look for the NDC number 54365-014-42 or lot number 4298581 on the packaging.
The recall record does not specify a remedy, so contact BD for guidance.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall D-0644-2026 — BD BD Hello, I own a BD that is covered by recall D-0644-2026 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.
