Z-2683-2016Class II

MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak...

Name: Z-2683-2016 MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak...
Creator: Teleflex Medical
Published: 2015-12-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-12-03 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia on 2015-12-03. FDA classified it as Class II and gives the reason as "Cracking may occur at the 15mm and 22mm ISO female connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2683-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Posted: 2016-08-29
Terminated: 2017-01-24
Recalling firm: Teleflex Medical
Product: MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Cracking may occur at the 15mm and 22mm ISO female connector.
Root cause tag: design
FDA root cause: Device Design
Action: INMED sent an Urgent - Field Safety Notice dated December 3, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to cease use and distribution of stock of the affected product batch and quarantine immediately. Customers are to return all affected product to MAQUET. An Acknowledgement form was included to be completed and returned to their MAQUET representative. If the product was distributed, they were instructed to provide the field safety notice to all of their customers who have received product in scope of the Field Action. Their customer is then required to complete the Acknowledgement form and return it to them. Should you require any further information or support concerning this issue, please contact your local MAQUET representative at [email protected]. INMED is committed to providing high quality, safe and effective products. W e sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service. For further questions, please call (610) 378-0131.
Quantity in commerce: 2,700 units
Distribution: US Distribution to the states of : FL, KS, and WV.
Product codes and lots: Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2683-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2683-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-29

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)