Recall Z-0167-2013— Sorin Group USA, Inc.

Name: FDA recall Z-0167-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-20

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2012-09-20, terminated 2013-01-28. It names one FDA 510(k) clearance: K011838. Product: SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.. Reason: 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..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Terminated: 2013-01-28
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K011838 — CENTRIFUGAL PUMPStockert Instrumente GmbH·cleared 2002-02-05

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

SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.

Reason for recall

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.

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