Recall Z-2374-2016 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Teleflex Medical
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
| Date | Aug 9, 2016 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | Cracks may occur at the 15mm and 22mm ISO female connector. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at fieldactions@maquet.com. For questions cont |
| Quantity | 2,700 ea. |
| Distribution | US Nationwide Distribution in the states of FL, KS and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.