BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
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
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- CareFusion 213, LLC
- Affected product
- Distributed Nationwide in the USA
- Risk or reason
- 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
- Remedy or action
- Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
- Official ID
- D-0648-2026