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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Recall Number Z-0053-2013
Classification Class II
Code Info Catalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381.
Product Distributed Qty 126 units
Reason For Recall Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

Event Detail

Event Id 62059
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
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