Recall Z-1040-2010 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Telefelx Medical
Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
| Date | Mar 9, 2010 (initiated Jan 12, 2010) |
| Status | Terminated |
| Reason | When turned on, the Neptune heater may cause an artifact on the patient's heart monitor. |
| Root cause | Device Design |
| Action | Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative |
| Quantity | 15,134 units |
| Distribution | U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland. |
| 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 |