MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artifi

FDA device recall Z-1008-2015 · posted 2015-02-06 · Terminated

Recall details

Recalling firm

Teleflex, Inc.

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.

Action taken

An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com.

Root cause

Process control

Status

Terminated

Product code

BYD

Quantity affected

18

Distribution

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

Date initiated

2014-12-04

Date posted

2015-02-06

Date terminated

2017-03-21

Location

Wayne, PA