Date Class I Recall Initiated: January 3, 2013
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Product: Reusable Breathing Circuit
Device Model: 900MR068
Lot Numbers: 110810 and 111020
Use: The Fisher & Paykel Healthcare reusable breathing circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.
Fisher & Paykel Healthcare Limited
15365 Barranca Parkway
Irvine, California 92618
Reason for Recall: The tubes used in the reusable breathing circuit have pinholes. 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.