# FDA recall Z-0401-2018

> **Sorin Group Deutschland GmbH** · Class II · device recall initiated 2017-10-30.

## Product

CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel.  It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.

## Reason for recall

Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.

## Distribution

Distributed domestically to     Distributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam

## Key facts

- **Recall number:** Z-0401-2018
- **Recalling firm:** Sorin Group Deutschland GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-30
- **Report date:** 2018-01-31
- **Termination date:** 2024-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2018

## Citation

> AI Analytics. FDA recall Z-0401-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0401-2018. Source: US FDA. Licensed CC0.

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