BD ChloraPrep Hi-Lite Orange recall
CareFusion 213, LLC recalled BD ChloraPrep Hi-Lite Orange on July 8, 2026 because of 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. It was sold nationwide.
Why it was recalled
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
What's recalled
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 7,650 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- CareFusion 213, LLC, El Paso, TX
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Distributed Nationwide in the USA - Status
- Ongoing
- Recall number
- D-0647-2026
- Source
- U.S. Food and Drug Administration
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