FDA Recall D-1509-2020
CareFusion 213, LLC · El Paso, TX
Class I — life-threatening Terminated 827 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
Reason for recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recall record
- Recall number
D-1509-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
- Recall initiated
- 2020-06-23
- Classified by FDA Center
- 2020-08-19
- FDA published
- 2020-08-26
- Terminated
- 2022-09-28
- Recalling firm
- CareFusion 213, LLC
- Firm location
- El Paso, TX
Drug identification
- Brand name(s)
- CHLORAPREP ONE-STEP
- Generic name(s)
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Manufacturer(s)
- CareFusion 213, LLC
- NDC(s)
54365-400- Route(s)
- TOPICAL