Date Initiated by Firm |
September 29, 2003 |
Date Posted |
December 10, 2003 |
Recall Status1 |
Terminated 3 on March 01, 2004 |
Recall Number |
Z-0180-04 |
Recall Event ID |
27436 |
Product Classification |
Ventilator, Non-Continuous (Respirator) - Product Code BZD
|
Product |
ComfortGel 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 Contact |
David J. Vanella 724-733-5866
|
Manufacturer Reason for Recall |
product does not contain built in exhalation port
|
FDA Determined Cause 2 |
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
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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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