# FDA recall Z-2104-2018

> **Datascope Corporation** · Class III · device recall initiated 2016-03-11.

## Product

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

## Reason for recall

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the  monitor display of H/S DISCONNECT AT CUVETTE.

## Distribution

The products were distributed to the following US states: AL, OR, and TX.

## Key facts

- **Recall number:** Z-2104-2018
- **Recalling firm:** Datascope Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-03-11
- **Report date:** 2018-06-13
- **Termination date:** 2019-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2018

## Citation

> AI Analytics. FDA recall Z-2104-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2104-2018. Source: US FDA. Licensed CC0.

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