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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 20, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 18, 2005
Recall Number Z-0929-04
Recall Event ID 28916
Product Classification Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
Product Concha IV Plus Heated Humidifier
Code Information All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
Recalling Firm/
Manufacturer		 Hudson Respiratory Care Inc
27711 Diaz Rd
Temecula CA 92590-3425
For Additional Information Contact Jeannie Denning
800-848-3766
Manufacturer Reason
for Recall		 Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.
FDA Determined
Cause 2		 Other
Action Firm will call hospitals to arrange for a visit to update the software.
Quantity in Commerce 1049
Distribution Nationwide.
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.
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