A GE Healthcare voluntary recall of an anesthesia devices part has received a Class I classification from the FDA, which means the fault might cause serious health problems or death.
The part involved is the GE Healthcare Multi Absorber Original Disposable, a disposable product attachment that removes carbon dioxide as a patient exhales, according to the FDA. The part is used in the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). All four devices are used on patients under the care of a health professional during general anesthesia procedures.
The faulty Multi Absorbers were made between August 2012 and May 2013 and distributed between August 2012 and July 2013. The problem involves a thin wall condition, which may lead to small holes in the water (drain) tube, potentially causing loss of anesthetic gases, ventilations and oxygenation for patients.
GE Healthcare's Advanced Breathing System, as shown on the company's website.
GE notified affected customers on September 19, 2013 of the problem via FedEx overnight mail.
The voluntary corrective action was issued after GE received customer complaints and product returns, which then turned up drain tube leaks upon further inspection, according to a GE Healthcare news release. As of early January, GE said no patient injuries had been reported.
