Recall Z-2036-2012 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
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.
| Date | Jul 19, 2012 (initiated Jun 12, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063758 | CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R Teleflex Medical, Apr 23, 2007 |