# FDA recall D-0373-2021

> **CareFusion 213, LLC** · Class I · drug recall initiated 2021-04-20.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0373-2021
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-20
- **Report date:** 2021-05-19
- **Termination date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Paso, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0373-2021

## Citation

> AI Analytics. FDA recall D-0373-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0373-2021. Source: US FDA. Licensed CC0.

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