FDA ISSUES CLASS I RECALL FOR VENTILATOR
The FDA has issued a Class I recall of the Respironics PLV Continuum Ventilator (PLVC I). The device is manufactured by Respironics California in Carlsbad, Calif., and was recalled by the company March 20. It is a mechanical ventilator used to control or assist breathing and meant for use in the home, institutional and portable settings. It can be used for both invasive and noninvasive ventilation, the agency said.
The device is being recalled due to a design flaw that can cause lead wires in the airflow valve to break. This causes the device to stop providing mechanical ventilation, the agency said. Respironics did not comment by press time.
The recall notice can be viewed at http://www.fda.gov/cdrh/recalls/recall-032006.html (http://www.fda.gov/cdrh/recalls/recall-032006.html).