FDA recall Z-1327-2025

Spectrum Medical Inc · Class II · device

Product

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 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.

Key facts

Status
Ongoing
Initiation date
2025-01-16
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Mill, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2025