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Z-0401-2018 Class II Terminated

Recalled by Sorin Group Deutschland GmbH — Munich, N/A

FDA device recall Z-0401-2018 was initiated by Sorin Group Deutschland GmbH on October 30, 2017 and is designated Class II. 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. The recall status is terminated (terminated January 26, 2024). Affected quantity: 1,318 units.

Recall Details

Product Type: Devices
Report Date: January 31, 2018
Initiation Date: October 30, 2017
Termination Date: January 26, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,318 units

Product Description

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 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 Pattern

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

Code Information

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.