FDA Recall D-0243-2026
CareFusion 213, LLC · El Paso, TX
Class II Ongoing 148 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Reason for recall
Lack of Assurance of Sterlity
Recall record
- Recall number
D-0243-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2025-12-17
- Classified by FDA Center
- 2025-12-30
- FDA published
- 2026-01-07
- Recalling firm
- CareFusion 213, LLC
- Firm location
- El Paso, TX
Drug identification
- Brand name(s)
- CHLORAPREP SWABSTICK
- Generic name(s)
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Manufacturer(s)
- CareFusion 213 LLC
- NDC(s)
54365-401- Route(s)
- TOPICAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.