FDAFDA · Food and drugs·Recall number Z-0053-2013
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Published October 17, 2012 · Recall initiated: September 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- 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.
- Lot
- Catalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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