BD ChloraPrep Hi-Lite Orange 26 mL Applicator — Class I drug recall D-0373-2021
Terminated recall by CareFusion 213, LLC, reported 2021-05-19, distributed nationwide. Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activat
| Recall number | D-0373-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2021-04-20 |
| Classified | 2021-05-10 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 707,050 eaches |
| Reason classes | foreign material |
| NDC | 54365-0400, 54365-0400-38 |
| Lot numbers | 0108186, 0327867, 0327868, 0328213, 0328947, 0328949, 0329475, 0329477, 0330457, 0330606, 0330955, 0333826, 0333852, 0333855, 0334119, 0335029, 0335787, 0335792, 0336051, 0336506, 0336972, 0337025, 0337245, 0338542, 0338653, 0338656, 0338852, 0339071, 0339457, 0339892 |
| Expiration dates | 2023-04-30, 2023-11-30 |
Product
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38
Reason for recall
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
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-0373-2021. 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.