Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A

Reason: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

Code information: Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

Distribution pattern: US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.