Carefusion 213, Llc: Chloraprep Frepp, Clear, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol) 500 X 1
ChloraPrep FREPP Recall Summary CareFusion 213, LLC is recalling ChloraPrep FREPP skin antiseptic applicators (1.5 mL bottles, 500 per case) because they may not be sterile. The applicators were meant to be sterilized before sale but were instead sold directly to customers in their unsterilized state. This recall affects products distributed nationwide across all U.S. states and Washington, D.C.
- Recalling firm
- CareFusion 213, LLC
- Product
- ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
- 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/883ce055-8e4e-4a7a-89c3-7444514d5b1a