FDA (Devices) recall action 77717
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems because plastic fibers may allow hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling STOCKERT Heater-Cooler System 3T units because plastic heat exchanger fibers may allow excessive hydrogen peroxide diffusion.