Recall Z-0167-2013
Sorin Group USA, Inc. · initiated September 20, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. 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.
Codes / lots: Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954.
Reason for recall
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
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.
Details
- Recall number
- Z-0167-2013
- Initiated
- September 20, 2012
- Posted by FDA
- October 29, 2012
- Terminated
- January 28, 2013
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Quantity
- 8 units (2 units USA and 6 units OUS)
- Distribution
- Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
- Recalling firm
- Sorin Group USA, Inc., Arvada, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0166-2013 Class II | SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121…Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the… | 09/20/2012Terminated |