FDAFDA · Food and drugs·Recall number Z-2036-2012
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.
Published July 25, 2012 · Recall initiated: June 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
- Lot
- Catalog #425-00, 425-10 and 425-30.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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