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U.S. Department of Health and Human Services

Class 1 Device Recall ComfortGel Nasal Mask

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  Class 1 Device Recall ComfortGel Nasal Mask see related information
Date Initiated by Firm September 29, 2003
Date Posted December 10, 2003
Recall Status1 Terminated 3 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/
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville PA 15668
For Additional Information Contact David J. Vanella
Manufacturer Reason
for Recall
product does not contain built in exhalation port
FDA Determined
Cause 2
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.