Carefusion 213, Llc: Bd Chloraprep Clear, (2% W/v Chlorhexidine Gluconate (chg), And 70% V/v Isopropyl Alcohol (ipa), Packaged As A) 100 X
BD ChloraPrep Clear Recall Summary BD ChloraPrep Clear skin antiseptic applicators (100 or 250 count cases) were distributed without proper sterility assurance because unsterilized products intended for further processing were mistakenly sent through regular distribution channels instead. The affected products were distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, meaning the use of these products could cause serious adverse health effects or death.
- Recalling firm
- CareFusion 213, LLC
- Product
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, 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/c6639712-bcde-47d5-a43b-4bcf722ebb0f