Concha IV Plus Heated Humidifier
FDA Recall Z-0929-04 · Posted 2004-07-20
Recalling FirmHudson Respiratory Care Inc
Recall StatusTerminated
Product CodeBTT
Date Initiated2004-04-20
Date Terminated2005-01-18
Product Quantity1049
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.
Firm Action
Firm will call hospitals to arrange for a visit to update the software.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.