Carefusion 213, Llc: Bd Chloraprep Hi-lite Orange, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol) Packaged As: A) 25 X
Recall Summary BD ChloraPrep Hi-Lite Orange skin antiseptic applicators (25 or 50-pack cases) are being recalled because they were distributed without proper sterilization when they should have been sent for sterilization before use. The products were shipped to customers nationwide across all U.S. states and the District of Columbia, and were manufactured by CareFusion 213, LLC, a subsidiary of Becton Dickinson and Company.
- Recalling firm
- CareFusion 213, LLC
- Product
- 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.
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-11
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/76936ed3-de90-4856-a1b9-127f2b362faf