Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
FDA Recall Z-2036-2012 · Posted 2012-07-19
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2012-06-12
Date Terminated2014-01-28
Product Quantity14,794 each
Reason for Recall
Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.
Firm Action
Teleflex sent Urgent Medical Device Notification letters dated June 12, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to complete the enclosed Acknowledgement Form and return per the instructions provided. Once the form is received, Teleflex Medial will schedule for a technician to come to their facility and exchange the affected product. For questions call your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.