Recall Z-0856-2014— Sorin Group Deutschland GmbH

Name: FDA recall Z-0856-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-04

Class II · Terminated

Class II FDA medical device recall by Sorin Group Deutschland GmbH, initiated 2013-12-04, terminated 2015-12-28. It names 2 FDA 510(k) clearances: K093882, K071318. Product: 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: 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..

Recalling firm: Sorin Group Deutschland GmbH
Classification: Class II
Status: Terminated
Initiated: 2013-12-04
Terminated: 2015-12-28
Firm location: Munchen, Germany

510(k) clearances named in this recall

2 on FDA's record

K093882 — SORIN C5 SYSTEM MODEL 58-00-00Sorin Group Deutschland GmbH·cleared 2010-01-15
K071318 — MODIFICATION TO: STOCKERT S5 SYSTEMSorin Group Deutschland GmbH·cleared 2007-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.