PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 25, 2012 Initiated: June 12, 2012 #Z-2036-2012

Product Description

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.

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.

Details

Recalling Firm
Teleflex Medical
Units Affected
14,794 each
Distribution
Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teleflex Medical. Units affected: 14,794 each.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2036-2012.