BD ChloraPrep Clear 3 mL Applicators — Class I drug recall D-1509-2020
Terminated recall by CareFusion 213, LLC, reported 2020-08-26, distributed in GU, PR. Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
| Recall number | D-1509-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2020-06-23 |
| Classified | 2020-08-19 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2022-09-28 |
| Distributed | GU, PR |
| Countries outside the US | AE, BH, BR, CL, CO, GB, HK, IE, IL, KW, OM, QA, SA, SG |
| Quantity | 12,500 applicators |
| Reason classes | sterility |
| Pathogens | mold |
| NDC | 54365-0400, 54365-0400-32 |
| Lot numbers | 0065386, 0091666 |
| Expiration dates | 2023-02-28, 2023-03-31 |
Product
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
Reason for recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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-1509-2020. 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.