Class 1 Device Recall ComfortGel Nasal Mask

• Date Initiated by Firm: September 29, 2003
• Date Posted: December 10, 2003
• Recall Status: Terminated on March 01, 2004
• Recall Number: Z-0178-04
• Recall Event ID: 27436
• 510(K)Number: K954207
• Product Classification: Ventilator, Non-Continuous (Respirator) - Product Code BZD
• Product: ComfortGel Nasal Mask size small
• Code Information: Part number 1009041; Lot numbers 030612, 030418, 030417, 030415, 030409, 030321, 030320, 030316, 030312, 030311, 030310, 030306, 030305, 030303, and 030228.
• Recalling Firm/ Manufacturer: Respironics, Inc.; 1001 Murry Ridge Lane; Murrysville PA 15668
• For Additional Information Contact: David J. Vanella; 724-733-5866
• Manufacturer Reason for Recall: product does not contain built in exhalation port
• FDA Determined Cause: Other
• Action: The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
• Quantity in Commerce: 5293 units
• Distribution: The products were shipped to sleep centers nationwide and in Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BZD and Original Applicant = RESPIRONICS, INC.