Z-0857-2014 Class II Terminated
FDA device recall Z-0857-2014 was initiated by Sorin Group Deutschland GmbH on December 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated December 28, 2015). Affected quantity: 75.
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