Z-2036-2012Class II

Hudson RCI Concha Therm Neptune Humidifier, Rx Only

Name: Z-2036-2012 Hudson RCI Concha Therm Neptune Humidifier, Rx Only
Creator: Teleflex Medical
Published: 2012-06-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2012-06-12 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing... on 2012-06-12. FDA classified it as Class II and gives the reason as "Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment". 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-2036-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Posted: 2012-07-19
Terminated: 2014-01-28
Recalling firm: Teleflex Medical
Product: Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex sent Urgent Medical Device Notification letters dated June 12, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to complete the enclosed Acknowledgement Form and return per the instructions provided. Once the form is received, Teleflex Medial will schedule for a technician to come to their facility and exchange the affected product. For questions call your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 14,794 each
Distribution: Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Product codes and lots: Catalog #425-00, 425-10 and 425-30.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2036-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2036-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

Product code BTT

K063758Class IIChoncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00RTeleflex Medical / cleared 2007-04-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)