Carefusion 213, Llc: Bd Chloraprep Hi-lite Orange, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol (ipa)), Packaged As A) 100 X 10
Recall Summary BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic solution) are being recalled nationwide because unsterilized products intended for further processing were distributed to customers instead of going through proper sterilization channels. The affected products are 100-count cases with catalog numbers 930715NS and 930715NSB (NDC 54365-400-35), distributed by CareFusion 213, LLC.
- Recalling firm
- CareFusion 213, LLC
- Product
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, 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/480bdfdb-d935-4a6e-bfd7-f195e74d4f85