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U.S. Department of Health and Human Services

Class 2 Device Recall S5 Mast Roller Pump System

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 Class 2 Device Recall S5 Mast Roller Pump System see related information
Date Posted January 26, 2011
Recall Status1 Terminated on July 13, 2012
Recall Number Z-0965-2011
Recall Event ID 57609
510(K)Number K060053 
Product Classification Cardiopulmonary Bypass Heart-Lung Machine Console - Product Code DTQ
Product SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004.

Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Code Information Serial Numbers: 50K00314 to 50K00694
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
303-467-6306
Manufacturer Reason
for Recall
Touch screen may become unresponsive, inhibiting user input.
FDA Determined
Cause 2
Device Design
Action All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.
Quantity in Commerce 79 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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