# FDA recall Z-2178-2018

> **Datascope Corporation** · Class II · device recall initiated 2017-07-27.

## Product

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035    Product Usage:  The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

## Reason for recall

There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

## Distribution

The products were distributed to the following US states: IA and FL.

## Key facts

- **Recall number:** Z-2178-2018
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-27
- **Report date:** 2018-06-20
- **Termination date:** 2020-02-07

- **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-2178-2018

## Citation

> AI Analytics. FDA recall Z-2178-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2178-2018. Source: US FDA. Licensed CC0.

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