BD ChloraPrep Hi-Lite Orange — Class II drug recall D-0643-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-07-08, distributed nationwide. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing
| Recall number | D-0643-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-06-29 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,800 units |
| Reason classes | sterility |
| NDC | 54365-0400, 54365-0400-35 |
| Model numbers | 930715NS |
| Expiration dates | 2026-12-31, 2027-02-28, 2027-03-31, 2027-08-31, 2027-09-30 |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0643-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.