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On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 2021 product recall and the health risks posed by the foam used in the recalled products.
Products in this recall include:
“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. 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,” says Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
After learning many were unaware of the product recall or have received insufficient information, the FDA determined a notification order was in order to eliminate the unreasonable risk of harm posed by the recalled products due to the fact that Philips Respironics notification efforts to date have been inadequate.
The FDA order also recommends that Philips provide detailed information to those impacted by the recall about the replacement process and take additional measures to communicate with the public regarding the recall.
Find more information on the FDA’s Actions with the Philips Respironics recall.
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The recalled devices have sound abatement foam liners that can break down and release particles that can be inhaled or ingested; these devices have no filter to prevent this from happening. The foam also can emit vapors of toxic chemicals beyond the safe exposure level and present life-threatening health hazards to users
The foam is more likely to break down with older devices and devices that are used more often. Climate and environmental conditions (i.e., high heat and humidity in locations where devices are stored) can exacerbate the breakdown. Also, according to Philips, unapproved cleaning processes, such as ozone or ultraviolet light can worsen foam degradation.
If you or a loved one developed cancer, respiratory issues, or other serious health problems after using one of the defective Philips CPAP machines, contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will help you determine if your Philips breathing device is the cause of your health issues.
Call us today at (877) 284-6600. One of our experienced staff will speak with you personally and will provide you with a free, no-obligation review of your case.
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