Centrifugal Pump

• 2 recalls, same reason

  • Terminated Z-2440-2020 FDA Class II ·initiated 26 Aug 2019
  • Terminated Z-2439-2020 FDA Class II ·initiated 26 Aug 2019

  The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.

• 2 recalls, same reason

  • Terminated Z-0167-2013 FDA Class II ·initiated 20 Sep 2012
  • Terminated Z-0166-2013 FDA Class II ·initiated 20 Sep 2012

  Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.

510(k) Number

K011838 ↗

FDA Product Code

DWA

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert Coronary Perfusion Cannulae

  Class II

  FDA 510(k) K022280 Active Cleared 11 Oct 2002

• Stockertir Purge Control (APC) System

  Class II

  FDA 510(k) K041558 Active Cleared 2 Jul 2004

• Stockert Centrifugal Pump System with Tubing Clamp

  Class II

  FDA 510(k) K032213 Active Cleared 29 Aug 2003

• Stockert Scp Rhythm

  Class II

  FDA 510(k) K042374 Active Cleared 23 Sep 2004

• Stockert Centrifugal Pump Console

  Class II

  FDA 510(k) K020571 Active Cleared 23 Sep 2002

• Siii Alarm Amplifier

  Class II

  FDA 510(k) K011088 Active Cleared 2 May 2001

See all devices from Stockert Instrumente GmbH →