FDA regulators slapped their highest-risk Class I label on a recall of anesthesia system components made by Vital Signs Devices, a company that GE Healthcare (NYSE:GE) recently sold to CareFusion (NYSE:CFN).
The recall, issued over potential leakages in a drain tube, was initiated in September 2013 and updated earlier this month to reflect the FDA’s added warnings.
The Multi Absorber Original Disposable is designed to attach to the GE Healthcare Advanced Breathing System, the GE Healthcare EZchange manifold, the GE Healthcare Compact Block and the GE Healthcare Compact Block II, according to the FDA notice.
Failures in the drain tube "may result in loss of anesthetic gases, ventilations and oxygenation," the FDA warned. Such a lapse could lead to patient harm or death.
Vital Signs late last month officially changed hands from GE to CareFusion, a deal valued at $500 million.