Recall Z-0166-2013 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Sorin Group USA, Inc.
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.
| Date | Oct 29, 2012 (initiated Sep 20, 2012) |
| Status | Terminated |
| Reason | 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 | Mixed-up of materials/components |
| Action | 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 directe |
| Quantity | 12 units (3 units USA and 9 units OUS) |
| Distribution | Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011838 | CENTRIFUGAL PUMP Stockert Instrumente GmbH, Feb 5, 2002 |