Sorin Group Deutschland GmbH Recall: S5/C5 Heart-lung machine Product Usage: The StOckert
Sorin Group Deutschland GmbH Recall: S5/C5 Heart-lung machine Product Usage: The StOckert is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sorin Group Deutschland GmbH; Product: S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardio
| Recalling firm | Sorin Group Deutschland GmbH |
|---|---|
| Product | S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. |
| Reason for recall | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA. |
| Recall initiated | 20131204 |
| Recall number | Z-0856-2014 |
| Category | device |
| Country | Germany |
$29/mo
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