FDA-Drug2026-07-08Class IIPROCESSING DEFECT
BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
What this means
BD ChloraPrep CLear applicators intended for further processing and sterilization were distributed directly to customers without being sterilized first. The product is a skin antiseptic used before medical procedures. No injuries have been reported.
- Check if you have BD ChloraPrep CLear lot 4190081 with expiration 06/30/2027.
- Do not use unsterilized applicators on patients or for any medical procedure.
- Contact your supplier or BD/CareFusion for return or replacement instructions.
The agency's original wording
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
100 units
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2026More CareFusion recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
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