Recall Z-0857-2014— Sorin Group Deutschland GmbH
Class II · Terminated
Class II FDA medical device recall by Sorin Group Deutschland GmbH, initiated 2013-12-04, terminated 2015-12-28. It names one FDA 510(k) clearance: K112225. Product: 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: 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
1 on FDA's recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.