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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

Product Description SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. 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.
Recall Number Z-0166-2013
Classification Class II
Code Info Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.
Product Distributed Qty 12 units (3 units USA and 9 units OUS)
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.

Event Detail

Event Id 63381
Product Type Devices
Status Ongoing
Recalling Firm Sorin Group USA, Inc.
City Arvada
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.