Device Recall Stockert S5 System I Sorin C5 System

S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00

Cardiovascular Devices

2

No

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.

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.