FDA Drug recall D-0373-2021
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution,…
- FDA Drug
- Class I
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution,… by Carefusion 213, citing defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0373-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-04-20 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | US |
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
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Identifiers
| ndc | 54365-400-38 |
|---|---|
| code_info | Lot #: 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 033045…Lot #: 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892 0339457, Exp. 11/30/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0373-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.