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.
Recall
- Recall Number
- Z-0787-2022
- Event Number
- 89312
- Firm
- LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany
- FEI Number
- 3002808267
- Product Code
- DWA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 17, 2021
- Terminated
- January 8, 2024
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.
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
On 12/17/2021, the firm notified affected customers via email using a letter titled, "URGENT MEDICAL DEVICE CORRECTION FA-CP-MUN-2021-001." The letter indicated the following actions to be taken by the customer: Using the attached Customer Response Form (Attachment 1), please respond by email to [email protected] to confirm the receipt of this letter and that you have read and understood its content. No further action is requested. A LivaNova authorized technician will contact you to schedule an appointment and correct the devices with the missing ferrite ring. Any affected device currently in use may continue to be used without limitation. For questions regarding this Medical Device Correction, please contact a LivaNova sales rep or send an e-mail LivaNova Quality Assurance Team at [email protected]. Please, complete this response form and return it via e-mail to [email protected] no later than December 31st, 2021.
US distribution in states of FL, TX, and NE
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