FDA recall Z-0787-2022

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 for recall

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

Distribution

US distribution in states of FL, TX, and NE

Key facts

Status

Terminated

Initiation date

2021-12-17

Report date

2022-03-23

Termination date

2024-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2022