Vital Signs Devices, a GE Healthcare Company, has recalled the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain) tube. This may result in a loss of anesthetic gases, ventilation, and oxygenation.
The GE Healthcare Multi Absorber Original Disposable is a disposable product attachment that is used with 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). These devices are used under constant supervision of a qualified healthcare professional during procedures where patients undergo general anesthesia. The Multi Absorber removes carbon dioxide as the patient exhales.
Affected absorbers were found to leak due to a hole in the drain tube. The affected product number is M1173310 containing lot numbers 12001 through 13031. Products with lot numbers 13032 and higher are not affected by the recall. The recalled products were manufactured between August 2012 and May 2013 and were distributed between August 2012 and July 2013.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe