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The U.S. Food and Drug Administration (FDA) issued a recall on several lots of reusable breathing circuits manufactured by Fisher & Paykel Healthcare. According to an FDA press release, the Class I recall was issued after defects were found in tubes transporting gas through the devices.
A reusable breathing circuit is used to deliver oxygen to adult patients receiving breathing therapies. In Nov. 2012, the company sent a letter to those who had purchased one of devices explaining that small pinholes were found in the tubing on devices from lot numbers 110810 and 111020. If leak testing does not detect the holes before the unit is sold, gas from oxygen therapies may leak from the tubes causing gas pressure to drop. A drop in pressure means patients may not receive their intended ventilation therapy, potentially resulting in patient death.
Those affected by the recall have been instructed to remove and destroy any affected breathing circuits found in inventory. Replacements will be dispatched upon receipt of the Product Recall Response form. Any questions regarding the recall should be directed to the product’s manufacturer.
If you or a loved one has suffered health problems or death as a result of a reusuable breathing circuit, contact John Foy and Associates. Our Georgia drug recall attorneys will fight to get you the compensation you and your family deserve! Please give us a call at 404-400-4000.
