Recall Z-0401-2018— Sorin Group Deutschland GmbH

Name: FDA recall Z-0401-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-30

Class II · Terminated

Class II FDA medical device recall by Sorin Group Deutschland GmbH, initiated 2017-10-30, terminated 2024-01-26. It names one FDA 510(k) clearance: K112225. 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.. Reason: 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..

Recalling firm: Sorin Group Deutschland GmbH
Classification: Class II
Status: Terminated
Initiated: 2017-10-30
Terminated: 2024-01-26
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)Sorin Group Deutschland GmbH·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.