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U.S. Department of Health and Human Services

Medical Devices

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ComfortGel Nasal Masks

Class I Recall
Date Recall
Initiated:
September 29, 2003
Product:
ComfortGel Nasal Masks
Use:
These masks are used on patients being treated for obstructive sleep apnea or for respiratory failure and are used in conjunction with CPAP devices.
Recalling Firm:
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668-8550
Reason for Recall:
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.
Public Contact:
David J.Vanella
Director, Quality Assurance – Homecare Division
(724) 733-5866
FDA District:
Philadelphia
FDA Comment:
Use of this mask without the separate exhalation device exposes patients
to a high risk of serious health consequences.