Home / Recalls / Medical Devices
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c
Recalled October 30, 2024 · FDA recall Z-0224-2025 · Spectrum Medical
Hazard
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. · FDA Class II
Units
172 units
Sold at
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.
Description
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Product
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
Manufacturer(s)
Spectrum Medical Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →