# FDA recall Z-2935-2020

> **CareFusion 303, Inc.** · Class II · device recall initiated 2020-08-04.

## Product

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

## Reason for recall

Infusion pump component defect may result in interruption of patient monitoring

## Distribution

U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None

## Key facts

- **Recall number:** Z-2935-2020
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-04
- **Report date:** 2020-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2935-2020

## Citation

> AI Analytics. FDA recall Z-2935-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2935-2020. Source: US FDA. Licensed CC0.

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