Class II

Medical Device Recall: Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

Spectrum Medical Ltd. · March 13, 2023

Reason for Recall

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Distribution

US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.

States Affected

NATIONWIDE

Quantity Affected

172 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0224-2025

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.