Z-2374-2016Class II

Servo Humidifier 163, Model 01-06-8125-8, REF 6419365

Name: Z-2374-2016 Servo Humidifier 163, Model 01-06-8125-8, REF 6419365
Creator: Teleflex Medical
Published: 2015-12-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-12-03 / Terminated

FDA source

Teleflex Medical began a recall of Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over... on 2015-12-03. FDA classified it as Class II and gives the reason as "Cracks may occur at the 15mm and 22mm ISO female connector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2374-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Posted: 2016-08-09
Terminated: 2017-04-14
Recalling firm: Teleflex Medical
Product: Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical 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 humidity gases breathed in by the patient.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Cracks may occur at the 15mm and 22mm ISO female connector.
FDA root cause: Release of Material/Component prior to receiving test results
Action: Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at [email protected]. For questions contact your local sales representative or Customer Service.
Quantity in commerce: 2,700 ea.
Distribution: US Nationwide Distribution in the states of FL, KS and WV.
Product codes and lots: Lots 201450, 201451, 201452, 201504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2374-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2374-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

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)