FDA-Drug2026-07-08Class IIPROCESSING DEFECT

BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

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-0652-2026

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