Recall Z-1008-2015 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Teleflex, Inc.
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial 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 humidify gases breathed in by a patient.
| Date | Feb 6, 2015 (initiated Dec 4, 2014) |
| Status | Terminated |
| Reason | Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur. |
| Root cause | Process control |
| Action | An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com |
| Quantity | 18 |
| Distribution | Distributed in the states of FL, MI, WV, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.