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U.S. Department of Health and Human Services

Class 2 Device Recall S5 Control Panel For Mast Roller Pump 85

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 Class 2 Recall
S5 Control Panel For Mast Roller Pump 85
see related information
Date Posted March 05, 2012
Recall Status1 Terminated on November 09, 2012
Recall Number Z-1152-2012
Recall Event ID 61208
Premarket Notification
510(K) Number
K060053 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Code Information Item number: 28-95-80; Serial numbers 50E60312 to 50E65208.
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004
Manufacturer Reason
for Recall
Touch screen may be unresponsive, inhibiting user input.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.
Quantity in Commerce 3 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates
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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