—#113635

Product

SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.

FDA product code: DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011838
Affected lot / code info: Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.

Why it was recalled

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The firm, Sorin Group USA, Inc., sent an "URGENT FIELD SAFETY NOTICE" dated September 20, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. Customers were instructed to discontinue use of and segregate affected product for return and replacement to the firm; to complete and return the attached Customer Response Form via fax to: 303-467-6502 or email to: yvonne.feyerherm@sorin.com; and if they have transferred the affected products to a third party, to pass this information to the Sorin Group. Further questions may be directed to Sorin Group 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 : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.

Timeline

Recall initiated: 2012-09-20
Posted by FDA: 2012-10-29
Terminated: 2013-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113635. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.