Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes
Posted Jan 07 2013 1:40pm
AUDIENCE: Risk Manager, Anesthesiology
ISSUE: 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. Usage of the defective device may result in patient death.
BACKGROUND: The Fisher & Paykel Healthcare Reusable Breathing Circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.
RECOMMENDATION: On Nov. 19, 2012, Fisher & Paykel issued an Urgent Medical Device Recall letter to inform customers of the problem and to provide them with a Product Recall Response form. Customers should examine their inventory and destroy and discard any affected circuits in their possession.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: