Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes
MedSun: Newsletter #81, February 2013
FDA MedWatch Safety Alert
FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the tubes used in the reusable breathing circuit. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
FDA MedWatch Safety Alert. Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes. January 7, 2013.