Recall Z-1051-2015 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Teleflex Medical
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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 Jan 12, 2015) |
| Status | Terminated |
| Reason | Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector. |
| Root cause | Process control |
| Action | Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at fieldacti |
| Quantity | 100 units |
| Distribution | Distributed to FL, KS, MI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.