Reported Mar 23, 2022 · Terminated
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5…
LivaNova Deutschland GmbH
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: LivaNova Deutschland GmbH · Lindberghstr. 25 · Munich, N/A · N/A
Is this the product you have?
Sorin Centrifugal Pump SystemCP5Drive Unit (Catalogue Item #60-01-04
- UDI04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device
- Lot codes and dates
- CP5 Drive Unit Serial Numbers60E03336 60E03339 60E03344 60E03347
- Amount recalled
- 4
Where it was sold
Why it was recalled
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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