Pinholes Lead to Fisher and Paykel Breathing Circuit Recall

A Class I recall has been initiated for Fisher and Paykel reusable breathing circuits, due to a risk that the tubes may contain pinholes that could lead to a loss of oxygen and patient death. 

The Reusable Breathing Circuit recall was announced by the FDA on January 3, after Fisher and Paykel Healthcare issued an Urgent Medical Device Recall letter in November to inform customers that the reusable breathing tubes may possess pinholes. This may cause gas leaks in the breathing system, resulting in a loss of pressure for the intended ventilation therapy.

The FDA has determined that the severity of the problem merited a Class I recall status, suggesting that continued use of the product poses a reasonable probability of serious health consequences or death.

The Reusable Breathing Circuits are non-heated breathing circuits intended for oxygen therapy delivery for adult patients. The breathing circuits were manufactured by Fisher and Paykel of Irvine, California between August 2011 and October 2011 and distributed between April 6,2012 through September 27, 2012. The recalled breathing circuits have model number 900MR068 and lot numbers 110810 and 111020.

The manufacturer’s Urgent Medical Device Recall letter to customers included a Product Recall Response Form that should be filled out after examining their inventory and destroying and discarding any affected circuits in their possession. Replacement circuits will be provided to customers upon receipt of the Product Recall Response form indicating the number of replacements required. Consumers may also contact Fisher and Paykel Healthcare at 1-800-446-3908, ext 5003.