Reported Feb 5, 2014 · Terminated
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary…
Sorin Group Deutschland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group Deutschland GmbH · Lindberghstrasse 25 · Munchen · N/A
Is this the product you have?
- S5/C5 Heart-lung machine Product UsageThe StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less
- Lot codes and dates
- S5 Item Number
10-80-0010-85-0028-9S-8028-95-8S
- C5 Item NumberS8-00-00
- S5 Item Number
- Amount recalled
- 323
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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