FDAFDA · Food and drugs·Recall number Z-0271-2013
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Published November 14, 2012 · Recall initiated: September 19, 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
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 determi
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group USA, Inc.
- Distributor
- 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.
- Lot
- Serial Numbers: 10E06219,10E06220, 10E06231-10E06234, 10E06239-10E06241, 10E06255-10E06273, 10E06286-10E06289, 10E06291-10E06355, 10E06359-10E06364, 10E06366, 10E06368-10E06383, 10E06385, 10E06387-10E06391,10E06395-10E06401, 10E06403-10E06447, 10E6502.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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