The U.S. Food and Drug Administration has sent a notice to Philips Respironics after patients and medical suppliers claimed that they were not made aware of a recall of certain ventilators.
In the notification order, FDA has asked Philips Respironics to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure and bilevel positive airway pressure machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane sound abatement foam used in those products.
FDA said that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, as the company’s notification efforts to date have been inadequate.
“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,” said Jeff Shuren, M.D., J.D., 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.”
FDA has ordered Philips Respironics to notify all device users, durable medical equipment suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products.
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