The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.
FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
Amsterdam-based Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators have been inadequate to date.
Last week, the company disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. The subpoena sought “information related to events leading to the Respironics recall.” Phillips said its subsidiaries are cooperating with investigators.
In an update issued on May 2, the FDA’s Center for Devices and Radiological Health (CDRH) proposed an order for Philips to submit a plan for the repair, replacement or refund of the purchase price of the recalled devices manufactured after November 2015.
The company has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring the submission of a plan for repairs, replacements or refunds, according to the agency.
A Philips spokesperson issued the following statement on the FDA update:
“We have been informed by the FDA that they are proposing to issue an order under section 518(b) of the Federal Food, Drug, and Cosmetic Act, in connection with the Philips Respironics recall for certain CPAP, BiPAP and mechanical ventilators. Philips is studying the information and intends to share its views with the FDA. We have been and continue to cooperate with the FDA.
“To date, Philips Respironics has produced a total of 1.1 million replacement devices and repair kits for customers and patients in the US, and aims to complete the vast majority of the repair and replacement program in 2022.”
The original story has been updated with a statement from Philips.
