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.
Check against the official notice below — it lists the full affected range.
Sorin Group Deutschland GmbH is recalling 1,318 units of its CP5 Centrifugal Pump system, which consists of a drive unit, emergency system, and pump control panel used with an Electrical Remote-Controlled (ERC) tubing clamp. The recalled devices are identified by Model No. 60-00-60 and specific reference and UDI numbers for each component. The system was distributed domestically and internationally to dozens of countries including Canada, Australia, Japan, Germany, France, and many others.
The recall was issued because the automatic line closure function of the ERC clamp, which is designed to activate when an air bubble is detected, may take longer to close than intended by the device's design specifications. The source does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, S Quantity: 1,318 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.