Recall Z-1051-2015— Teleflex Medical
Class I · Terminated
Class I FDA medical device recall by Teleflex Medical, initiated 2015-01-12, terminated 2016-05-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector..
- Recalling firm
- Teleflex Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-01-12
- Terminated
- 2016-05-10
- Firm location
- Durham, NC, United States
Product description
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.
Reason for recall
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.