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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 Masksee related information
Date Initiated by FirmSeptember 29, 2003
Date PostedDecember 10, 2003
Recall Status1 Terminated 3 on March 01, 2004
Recall NumberZ-0180-04
Recall Event ID 27436
Product Classification Ventilator, Non-Continuous (Respirator) - Product Code BZD
ProductComfortGel Nasal Mask size large
Code Information Part number 1009043; Lot numbers 030826, 030814, 030528, 030307, and 020822. 
Recalling Firm/
Manufacturer
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville PA 15668
For Additional Information ContactDavid J. Vanella
724-733-5866
Manufacturer Reason
for Recall
product does not contain built in exhalation port
FDA Determined
Cause 2
Other
ActionThe recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
Quantity in Commerce5293 units
DistributionThe products were shipped to sleep centers nationwide and in Canada.
Total Product Life CycleTPLC 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.
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