Home / Recalls / Sorin Group Deutschland GmbH / Z-0856-2014

Z-0856-2014 Class II Terminated

Recalled by Sorin Group Deutschland GmbH — Munchen

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: 323

Product Description

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.

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

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