Teleflex Medical recalls MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat…

Recall date

January 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1051-2015

FDA classification

Class I

Brand / firm

Teleflex Medical

Sold / distributed

Distributed to FL, KS, MI and WV.

Why it was recalled

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.