Recall Z-1558-2015 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
| Date | Apr 30, 2015 (initiated Apr 1, 2015) |
| Status | Terminated |
| Reason | Customer complaints were received of power to the unit ceasing and the display going blank. |
| Root cause | Nonconforming Material/Component |
| Action | Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it wit |
| Quantity | 7,228 units |
| Distribution | US Nationwide and Internationally to the countries of: Belgium and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN Teleflex, Inc., Mar 6, 2014 |