Teleflex, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1008-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: December 4, 2014

Date Posted: February 18, 2015

Recall Number: Z-1008-2015

Event ID: 70127

Reason for Recall:

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.

Status: Terminated

Product Quantity: 18

Code Information:

Batch Numbers: 201321, 201323, and 201324.

Distribution Pattern:

Distributed in the states of FL, MI, WV, and KS.

Voluntary or Mandated:

Voluntary: Firm initiated