The FDA proposed that an order should be issued to require Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.
FDA’s proposal regards the June 2021 recall of certain 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.
MassDevice reached out to Philips for comment. This story may be updated.