CareFusion recalls BD ChloraPrep Hi-Lite Orange solution due to lack of sterility assurance. Unsterilized applicators distributed outside intended channels pose infection risks. Check product lot numbers for affected batches.
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
CareFusion is recalling BD ChloraPrep Hi-Lite Orange solution because unsterilized applicators were distributed to customers outside the intended channel. This could lead to infection risks if used improperly.
The solution was distributed without proper sterilization assurance, meaning the applicators could be contaminated. This poses an infection risk if used on patients without proper sterilization.
Healthcare professionals and patients using the BD ChloraPrep Hi-Lite Orange solution for medical procedures are at risk. Those using the unsterilized applicators outside intended channels may face infection risks.
Check for product packaging labeled 'BD ChloraPrep Hi-Lite Orange (2% w/v chlorhexidine gluconate and 70% isopropyl alcohol)'. Look for lot numbers: 3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, 5084224.
Look for lot numbers on the packaging: 3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, 5084224.
The official recall notice states that unsterilized applicators were distributed outside the intended channel, posing infection risks. Do not use if you have the affected lot numbers.
The recall does not specify a remedy, so check the lot numbers and contact CareFusion if you have the affected products.
Check the product packaging for lot numbers listed: 3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, 5084224.
We’ve drafted a message you can send CareFusion to request your refund or repair — edit it as you like.
Subject: Recall D-0648-2026 — CareFusion CareFusion Hello, I own a CareFusion that is covered by recall D-0648-2026 from CareFusion. 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.
