Further Requirements Placed on the Company by the FDA Following June 2021 BiPAP and CPAP Machine Recall
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In our last blog post regarding the Philips Recall, "Philips Required by FDA to Notify Patients and Others of Recent Device Recall", we reported on the Food and Drug Administration (FDA)'s order to Philips Respironics to notify all patients and others of the June 14, 2021 recall of certain ventilators, CPAP, and BiPAP machines.
As of May 2022, Philips has now been required by the FDA to submit a plan for the repair and replacement of the recalled devices. According to a May 2022 Safety Communication document published by the FDA:
On May 2, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015. Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more).
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While that new May 2022 FDA document does not offer much information as to what comes next, it was noted this requirement is being issued in addition to the previous order of providing notification of the recall to customers:
This proposal is in addition to the FDA’s previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices. We will continue to update the public about the status of this recall and share more information when it becomes available.
As reported in our November 2021 article, "Philips CPAP and BiPAP Replacement Foam May Continue to Cause Issues", testing of the Philips Respironics manufacturing facility was conducted and found a certain sound abatement foam component of the machine was breaking down and being breathed in by patients. At this time, it is uncertain what medical effect these exposures have on the body, though the most serious possible resulting medical conditions for patients who used one of the recalled Philips Bi-Level PAP devices, Philips CPAP devices, or Philips Mechanical Ventilators are various types of cancers and organ failures.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.
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