Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. |
|---|---|
| Recall Number | Z-0275-2013 |
| Classification | Class II |
| Code Info | Serial Numbers: 58E00135; 58E00136 |
| Product Distributed Qty | 2 units (no product distributed within the US). |
| Reason For Recall | 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 determined to be the cause of some of these events. |
Event Detail
| Event Id | 63383 |
|---|---|
| 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 | 2012-09-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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