FDA (Devices) recall action 67199
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
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 is recalling S5/C5 Heart-lung machines and CP5 centrifugal pump systems due to pump speed control knob failures that result in no response.
Sorin Group is recalling 75 CP5 centrifugal pump systems due to reports of pump speed control knob failures that result in no response.