FDAHealthJune 11, 2026
CareFusion 213, LLC — BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog
⚠️ Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2026
Distributed Nationwide in the USA
What's affected?
- Product
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
- Brand
- CHLORAPREP ONE-STEP
- Lot code
- a)
Additional details
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,800 units.
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