FDA Device recall Z-0401-2018
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel by Sorin Group Deutschland, citing 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 CP….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0401-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-30 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Deutschland |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Model No. 60-00-60. Drive Unit: Ref #60-01-04, UDI 04033817900948. Emergency System: Ref #60-01-35, UDI 0403381790095…Model No. 60-00-60. Drive Unit: Ref #60-01-04, UDI 04033817900948. Emergency System: Ref #60-01-35, UDI 04033817900955. Pump Control Panel: Ref #60-02-60, UDI 04033817901006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2018%22
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