CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
Hudson RCI Concha Therm Neptune Humidifier recalled by Teleflex Medical
Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifier, distributed nationwide in the US. The recall was initiated on 12 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2036-2012
- FDA event ID
- 62284
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2012
- FDA classified
- 19 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2012 | Recall initiated by company | |
| 19 Jul 2012 | Classified by FDA | +37 days |
| 25 Jul 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Questions about this recall
Why was it 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 lots are affected?
Catalog #425-00, 425-10 and 425-30.
Where was it sold?
Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |