Enforcement Report - Week of November 7, 2012
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Event Detail
| Event ID | 63381 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Sorin Group USA, Inc. |
| City | Arvada |
| State | CO |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. | Class II | 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. | 12 units (3 units USA and 9 units OUS) | Z-0166-2013 |
| 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. | Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. | Class II | 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. | 8 units (2 units USA and 6 units OUS) | Z-0167-2013 |
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