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FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Maryellen Bizzack
Director, Marketing & Communications
(724) 387-5006
David Vanella
Director, Quality Assurance
(724) 733-5866
FOR IMMEDIATE RELEASE -- Murrysville, PA -- December 3, 2003 -- Respironics, Inc. (NASDAQ/NMS Symbol: RESP) has voluntarily recalled 5,293 ComfortGel® nasal masks distributed from September 5, 2003 through September 15, 2003. These nasal masks, which were part of Respironics initial launch of the ComfortGel Mask, have been recalled because the company discovered that some masks shipped to Home Health Care Providers or distributors did not contain a built-in exhalation port. The exhalation port is required to allow exhaled air to properly exhaust. The masks were shipped without the exhaust port used to exhaust all of the exhaled CO2, which potentially could result in patients re-breathing CO2, associated decreased oxygen levels and increased CO2 levels in the blood. The ComfortGel nasal mask can only be obtained through a physician prescription.
The ComfortGel masks are used in the treatment of Obstructive Sleep Apnea (OSA) in conjunction with a Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (Bi-PAP) device which supplies a continuous stream of air which keeps the patient’s airway open during sleep to diminish apnea, or awakening, episodes.
Respironics self-reported the exhalation port issue to the Food and Drug Administration District in Philadelphia, Pennsylvania on September 26, 2003, when the issue came to the company’s attention.
A corrective action was begun immediately in which Respironics contacted all customers who were shipped masks during the September 5 to September 15 timeframe. The company has completed contact with all customers who received shipments of the masks and will continue inspection and replacement efforts until all suspected masks are returned by customers. As of today, 82% of the recalled masks have been returned to Respironics and less than 3% have been determined to be affected.
There have been no patient injuries to date. Respironics will work closely with the FDA to ensure that all masks in question are returned to the company for thorough inspection and repair or replacement. Respironics, Inc. is notifying its distributors and customers by telephone and written communication and is arranging for return of all recalled products. Consumers with questions may contact the company at 1-800-345-6443.
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