Z-1008-2015Class I

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

Name: Z-1008-2015 MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture...
Creator: Teleflex, Inc.
Published: 2014-12-04
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-12-04 / Terminated / root cause: manufacturing process

FDA source

Teleflex, Inc. began a recall of 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... on 2014-12-04. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1008-2015
Classification: Class I
Status: Terminated
Initiated: 2014-12-04
Posted: 2015-02-06
Terminated: 2017-03-21
Recalling firm: Teleflex Medical
Product: 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 code: BYD Condenser, Heat And Moisture (Artificial Nose)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected].
Quantity in commerce: 18
Distribution: Distributed in the states of FL, MI, WV, and KS.
Product codes and lots: Batch Numbers: 201321, 201323, and 201324.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2015	Class I	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-06

Product code BYD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)