FDA-Device2024-10-30Class II
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.
Hazard
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Sold states
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.
Affected count
172 units
Manufactured in
Harrier 4, Meteor Business Park, Cheltenham Road East, Gloucester, N/A, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2025Don't want to check this manually?
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