PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: August 26, 2020 Initiated: June 23, 2020 #D-1509-2020

Product Description

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

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
12,500 applicators
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,
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by CareFusion 213, LLC. Units affected: 12,500 applicators.
Why was this product recalled?
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Which agency issued this recall?
This recall was issued by the FDA Drug on August 26, 2020. Severity: Critical. Recall number: D-1509-2020.