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U.S. Department of Health and Human Services


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ComfortGel Nasal Masks

Audience: Hospital Risk Managers, respiratory care professionals

The 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 may result.

[December 4, 2003 - Device Recall - FDA]