Sorin Group Deutschland GmbH recalls CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Elect

Recalled January 31, 2018 · FDA recall Z-0401-2018 · Sorin Group Deutschland

Hazard

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. · FDA Class II

Units

1,318 units

Sold at

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

Description

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.

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.

Manufacturer(s)

Sorin Group Deutschland GmbH

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →