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U.S. Department of Health and Human Services

Class 2 Device Recall Stockert S5/Sorin C5 System

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 Class 2 Recall
Stockert S5/Sorin C5 System
see related information
Date Posted November 08, 2012
Recall Status1 Terminated on January 18, 2013
Recall Number Z-0273-2013
Recall Event ID 63383
Premarket Notification
510(K) Numbers
K071318  K093882 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Information Serial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784.
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004
For Additional Information Contact Mr. Jack Ellison
303-467-6306
Manufacturer Reason
for Recall
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The firm, Sorin Group, sent an "URGENT FIELD SAFETY NOTICE" dated September 19, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. The customers were instructed to follow the provided instructions for the continued safe use of the Perfusion systems until they have been serviced or replaced by Sorin Group. The Sorin Group Service Team will contact the customer to schedule servicing and replacement of the affected product. The customers were also instructed to complete and return the Customer Response Form via fax to 303-467-6502 or by email to yvonne.feyerherm@sorin.com; assure this notice is distributed to all personnel who need to be aware of this notice; and if they have transferred the affected products to a third party, pass this information with them as well as with Sorin Group Customer Service at 1-800-650-2623. For questions regarding this notice, contact Sorin Group USA Customer Service at 1-800-650-2623.
Quantity in Commerce 3 units
Distribution Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
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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