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 (2% chlorhexidine gluconate and 70% isopropyl alcohol) in 25-count and 50-count cases have been recalled because they were distributed without proper sterilization. The products were intended to be sterilized before sale but were sent directly to customers instead. The recall affects products distributed nationwide across all U.S. states and territories.
- 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/e40be2a1-9b43-46b4-9677-f3b42bedb173