CareFusion 213, LLC drug recall: BD ChloraPrep Clear 1mL Applicators
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96262
- Recall initiated
- Feb 14, 2025
- Classified by FDA
- Mar 7, 2025
- Posted in Enforcement Report
- Mar 19, 2025
- Recalling firm
- CareFusion 213, LLC
- Firm location
- El Paso, TX, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 14, 2025. FDA classified it 21 days later, on Mar 7, 2025. Distribution reported by FDA: Nationwide and Canada CareFusion 213, LLC has 18 recalls in our records.
Recalled products (1)
D-0259-2025 Class I Ongoing
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Codes / lots: Lot #: 3200240, Exp 6/30/2026
Quantity: 205,440 applicators
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96262
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.