# FDA recall Z-2443-2019

> **CareFusion 303, Inc.** · Class II · device recall initiated 2019-07-01.

## Product

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion  for models 11634567 and 8300ADXeN933

## Reason for recall

Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2

## Distribution

US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC  OUS: Australia

## Key facts

- **Recall number:** Z-2443-2019
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-01
- **Report date:** 2019-09-11
- **Termination 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-2443-2019

## Citation

> AI Analytics. FDA recall Z-2443-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2443-2019. Source: US FDA. Licensed CC0.

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