ComfortGel Recall - Questions and Answers

Murrysville, PA - December 3, 2003

Please reference the Respironics Press Release for further information.

• The ComfortGel Nasal mask recall was a voluntary recall initiated by Respironics, Inc. in September, 2003.
• The recall involved a limited number of masks (5,293) distributed from September 5 through September 15, 2003 in the initial days of the ComfortGel product launch.
• The majority of the masks shipped during this timeframe were samples to Respironics field sales personnel and were still in their possession at the time of the recall.
• These 5,293 masks were recalled because the company discovered that some masks shipped to Home Health Care Providers, labs or distributors did not contain a built-in exhalation port required to allow exhaled air to properly exhaust. A mask without the proper port potentially could result in patients re-breathing CO2, associated decreased oxygen levels and increased CO2 levels in the blood.
• Respironics stopped shipping the ComfortGel on September 16th when it identified the potential problem and immediately began a corrective action in which we:
  • Notified those labs, distributors and customers who received the masks by telephone and written communication to arrange for return of all recalled products.
  • Thoroughly inspected all additional stock of the ComfortGel before resuming shipping of the product on September 17th.
• No ComfortGel masks shipped since September 17th are affected by this recall.
• The FDA was notified of this recall on September 26th. The FDA informed Respironics on December 3rd that the recall had been classified as a Class I recall. As a result, we were required to issue a press release on December 3 detailing the recall and corrective action that began on September 16th.
• As of today, 82% of the recalled masks have been returned to Respironics and less than 3% have been determined to be affected. Respironics has been working closely with distributors, customers and the FDA to ensure that all masks in question are returned to the company for thorough inspection and repair or replacement.

Q. Which model or part numbers were affected by this recall?
A. ComfortGel Nasal Mask size small PN 1009041, ComfortGel Nasal Mask size medium PN 1009042, ComfortGel Nasal Mask size large PN 1009043

Q. How does a patient/end-user know if they have an affected mask?
A. Please keep in mind that if your Home Health Care Provider received one of the masks in question, they were contacted in September. Arrangements were made to return the masks to Respironics, Inc.

Visually, if your exhalation elbow has a blue triangle logo printed on it, the exhalation port is CORRECT.

Patients/end-users should check the original packaging for one of three affected part numbers and then contact their Home Health Care Provider for assistance:

• ComfortGel Nasal Mask size small PN 1009041
• ComfortGel Nasal Mask size medium PN1009042
• ComfortGel Nasal Mask size large PN 1009043

Consumers with questions may contact Respironics Customer Service at 1-800-345-6443. .

Q. How many of distributors or patients/end-users received the recalled ComfortGel Mask?
A. 5,293 ComfortGel Masks were recalled. Of this total, over 4,000 masks were under Respironics control. Approximately 1,200 masks were delivered either directly to Home Health Care Providers, Labs or distributors.

Q. What are the affects of re-breathing CO2?
A. CO2 re-breathing can occur when the patient circuit does not adequately exhaust exhaled air. The common effects of re-breathing CO2 are dizziness, headaches or sleepiness.

Q. Has anyone been injured?
A. There have been no patient injuries to date.

Q. Was this recall just in the United States?
A. This recall was initiated in the U.S. and Canada only for a limited number of ComfortGel Masks. ComfortGel products distributed internationally are not affected.

Q. Have you completely discontinued manufacturing the ComfortGel Mask?
A. We have not discontinued manufacturing the ComfortGel Mask. Once the corrective action was taken, we re-commenced manufacturing the product in late September and have continued to manufacture it successfully since then.

Q. Why is the FDA now requiring Respironics to communicate this to the public?
A. The FDA informed Respironics on December 3 that the recall had been classified as a Class I recall. As a result, we issued a press release on December 3 detailing the recall and corrective action that was reported to the FDA on September 26.