Z-0857-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2014
- Initiation Date
- December 4, 2013
- Termination Date
- December 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75
Product Description
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.
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.
Distribution Pattern
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.
Code Information
Item Number: 60-02-60