—#113641

Product

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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071318, K093882
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The firm, Sorin Group, sent an "URGENT FIELD SAFETY NOTICE" dated September 19, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. The customers were instructed to follow the provided instructions for the continued safe use of the Perfusion systems until they have been serviced or replaced by Sorin Group. The Sorin Group Service Team will contact the customer to schedule servicing and replacement of the affected product. The customers were also instructed to complete and return the Customer Response Form via fax to 303-467-6502 or by email to yvonne.feyerherm@sorin.com; assure this notice is distributed to all personnel who need to be aware of this notice; and if they have transferred the affected products to a third party, pass this information with them as well as with Sorin Group Customer Service at 1-800-650-2623. For questions regarding this notice, contact Sorin Group USA Customer Service at 1-800-650-2623.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-09-19
Posted by FDA: 2012-11-08
Terminated: 2013-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.