The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all customers of the company’s June 14 recall of certain Philips Respironics ventilators.
The company recalled about 3.5 million ventilation devices after finding a defect that could cause cancer. The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects.
The FDA order also instructs Philips to maintain language to patients on its main recall webpage regarding the risk of using ozone cleaners on the recalled devices and to provide instructions for users to register their devices.
"The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process," stated Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
"Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company."