Reported Jan 31, 2018 · Terminated

CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an…

Sorin Group Deutschland GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sorin Group Deutschland GmbH · Lindberghstr. 25 · Munich, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • 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
Amount recalled
1,318 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2024 · Data as of Sep 19, 6:05 PM UTC

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