The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health posted a Class I recall notice for the ComfortGel Nasal Masks by Respironics, Inc. Murrysville, PA. These masks are used on patients being treated for obstructive sleep apnea or for respiratory failure and are used in conjunction with CPAP devices.
These devices work by exhausting all of the exhaled CO2 out of an exhalation port built into the mask. The user instructions inform the patient that the mask contains an exhalation port and does not require the use of a separate exhalation device. However, the product was distributed without the exhalation port. Without the port in the breathing circuit, it is likely that the patient will experience increased CO2 re-breathing and associated oxygen deficiency. In some cases, suffocation or other serious health consequences may result.
See your doctor if you have experienced serious side effects associated with a ComfortGel Nasal Mask. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Medical Devices & Implants
- Lung & Airway Disorders