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All product recalls associated with CardioQuip, LLC.
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Oct 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.