Consent decree mandates remediation plan following worldwide recall, FDA oversight ensures patient safety and compliance
The District Court for the Western District of Pennsylvania issued a permanent injunction against Philips, LLC, Respironics, and others, limiting the production and sale of CPAP and BiPAP machines in various Philips Respironics facilities in the U.S. due to safety concerns. This action follows a June 2021 recall of ventilators and sleep therapy devices—affecting 15 million devices worldwide—due to potential health risks related to degraded foam.
The decree mandated a Recall Remediation Plan, overseen by the Food and Drug Administration (FDA), to address impacted patients’ needs.
“The finalization of this decree is a significant milestone. Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” said Director Jeff Shuren of the FDA’s Center for Devices and Radiological Health. He stated that the action “is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”
As the Lord Leads, Pray with Us…
- For discernment for Director Shuren as he oversees the FDA’s Center for Devices and Radiological Health.
- For Commissioner Robert Califf as he heads the Food and Drug Administration’s efforts to determine the safety of health treatments and therapies.
Sources: Food and Drug Administration
