Z-1051-2015Class I

MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No...

Name: Z-1051-2015 MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No...
Creator: Teleflex Medical
Published: 2015-01-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-01-12 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 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)... on 2015-01-12. FDA classified it as Class I and gives the reason as "Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector". 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-1051-2015
Classification: Class I
Status: Terminated
Initiated: 2015-01-12
Posted: 2015-02-06
Terminated: 2016-05-10
Recalling firm: Teleflex Medical
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.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at [email protected] with questions or for support this issue.
Quantity in commerce: 100 units
Distribution: Distributed to FL, KS, MI and WV.
Product codes and lots: Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1051-2015	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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)