FDAFDA · Food and drugs·Recall number Z-0857-2014
CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Published February 5, 2014 · Recall initiated: December 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group Deutschland GmbH
- Distributor
- 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.
- Lot
- Item Number: 60-02-60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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