# FDA recall Z-0678-2020

> **Maquet Cardiovascular Us Sales, Llc** · Class II · device recall initiated 2019-12-03.

## Product

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161.  The device is a component of the ROTAFLOW System Console.

## Reason for recall

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

## Distribution

The products were distributed to the following US states:  ME, NV, NY, OH, PA, TX, and VA.

## Key facts

- **Recall number:** Z-0678-2020
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-03
- **Report date:** 2019-12-18
- **Termination date:** 2020-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2020

## Citation

> AI Analytics. FDA recall Z-0678-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0678-2020. Source: US FDA. Licensed CC0.

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