Warning
CareFusion 213 Recalls BD ChloraPrep FREPP Clear
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0623-2026Drug / Pharmaceutical
CareFusion 213 Recalls BD ChloraPrep FREPP Clear
CareFusion 213, LLC · Class II — Moderate Risk
Product Description
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Reason for Recall
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide inthe USA, as well as other foreign distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. CareFusion 213, LLC initiated the recall on May 28, 2026. Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact CareFusion 213, LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects and CareFusion recalls.