Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
Reported: March 23, 2022 Initiated: December 17, 2021 #Z-0787-2022
Product Description
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
Reason for Recall
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Details
- Recalling Firm
- LivaNova Deutschland GmbH
- Units Affected
- 4
- Distribution
- US distribution in states of FL, TX, and NE
- Location
- Munich, N/A
Frequently Asked Questions
What product was recalled? ▼
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.. Recalled by LivaNova Deutschland GmbH. Units affected: 4.
Why was this product recalled? ▼
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Low. Recall number: Z-0787-2022.
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