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U.S. Department of Health and Human Services

Class 2 Device Recall CP5 centrifugal pump system

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 Class 2 Recall
CP5 centrifugal pump system
see related information
Date Posted January 28, 2014
Recall Status1 Open
Recall Number Z-0857-2014
Recall Event ID 67199
Premarket Notification
510(K) Number
K112225 
Product Classification Control, Pump Speed, Cardiopulmonary Bypass - Product Code DWA
Product CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Code Information Item Number: 60-02-60
Recalling Firm/
Manufacturer
Sorin Group Deutschland GmbH
Lindberghstrasse 25
Munchen
For Additional Information Contact Amritt Khorran
303-467-6306
Manufacturer Reason
for Recall
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
FDA Determined
Cause 2
DESIGN: Device Design
Action Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.
Quantity in Commerce 75
Distribution Worldwide Distribution - US Nationwide.
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 = DWA and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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