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 skin antiseptic applicators are being recalled because unsterilized units were distributed to customers instead of being sent for sterilization as intended. The affected products are 100-count cases with specific catalog and NDC numbers manufactured by CareFusion 213, LLC. The recall affects customers nationwide across all U.S. states and Washington, D.C.
- 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/84d481f5-d63b-4949-8edd-79fbd8898239