CareFusion 213, LLC: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Ster
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- CareFusion 213, LLC
- Product
- 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 / hazard
- Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide inthe USA, as well as other foreign distribution.
- Recall initiated
- 2026-05-28
- Code info
- Lot # 4073005, Exp 03/31/2027
- Product quantity
- 178,000 applicators
- Voluntary mandated
- Voluntary: Firm initiated
- City
- El Paso
- State
- TX
- Country
- United States
- Event id
- 99114
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