If undetected during the standard leak test, pinholes in the tubes used in the reusable breathing circuit, model 900MR068, manufactured by Fisher & Paykel Healthcare could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy, according to the Class I recall issued by the FDA. Usage of the defective device may result in patient death, according to the FDA.
The Fisher & Paykel Healthcare Reusable Breathing Circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.
Healthcare professionals are encouraged to examine their inventory and destroy and discard any affected circuits in their possession. Questions should be directed to Fisher & Paykel Healthcare Limited at 1-800-446-3908, ext. 5003, Monday through Friday from 6 am to 5 pm (Pacific time).
More information on the recall can be found on the FDA’s website.