FDA recall Z-0224-2025

Spectrum Medical Ltd. · Class II · device

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

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.

Key facts

Status
Completed
Initiation date
2023-03-13
Report date
2024-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gloucester, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2025