← FDA ENFORCEMENT
D-0624-2026Class I

CareFusion 213, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
CareFusion 213, LLC
Product type
Drug
Status
Ongoing
Report date
2026-07-01
Distribution
Nationwide inthe USA, as well as other foreign distribution.
Firm state
TX
Product quantity
193,440 applicators
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Non-Sterility: Due to presence of Aspergillus penicillioides.

Product description

BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.

Code / lot info

Lot # 4032183, Exp 01/31/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →