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…

Recall date

October 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0401-2018

FDA classification

Class II

Brand / firm

Sorin Group Deutschland GmbH

Sold / distributed

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, M…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.