CareFusion 213 product recalled over sterility concerns

Recall date

June 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CareFusion 213, LLC recalls ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-L…

Recall number

D-1510-2020

FDA classification

Class I

Brand / firm

CareFusion 213, LLC

Sold / distributed

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,

Why it was recalled

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11