# FDA recall Z-2350-2021

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2021-06-08.

## Product

Terumo Advanced Perfusion System 1 Electronic Patient Gas System    Catalog #: 801188

## Reason for recall

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

## Distribution

International distribution in the country of Panama.

## Key facts

- **Recall number:** Z-2350-2021
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-08
- **Report date:** 2021-09-01
- **Termination date:** 2022-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2021

## Citation

> AI Analytics. FDA recall Z-2350-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2350-2021. Source: US FDA. Licensed CC0.

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