Recall archive / FDA device enforcement
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 S... — FDA record Z-0787-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 17, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- Classification
- Class III
- Recalling firm
- LivaNova Deutschland GmbH
- Quantity
- 4
- Agency-reported status
- Terminated
- Source record identifier
- Z-0787-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution in states of FL, TX, and NE
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 23, 2022
- Recall initiation date
- Dec 17, 2021
- Center classification date
- Mar 15, 2022
- Termination date
- Jan 8, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.