Spectrum Medical Inc: Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-V

Hazard

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

Details from the source

Reason for recall: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. Distribution: 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. Quantity: 1487 unit Lot/code info: Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

UPC codes

08051160300624

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.