Device product
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.
Z-1051-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70257
- Status
- Terminated
- Classification
- Class I
- Quantity
- 100 units
- Official record key
device-enforcement:Z-1051-2015
Official wording
Reason: Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
Code information: Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.
Distribution pattern: Distributed to FL, KS, MI and WV.
Derived failure modes
-
Unknown
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.