Z-1040-2010

Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and...

Name: Z-1040-2010 Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and...
Creator: Telefelx Medical
Published: 2010-01-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2010-01-12 / Terminated / root cause: design

FDA source

Telefelx Medical began a recall of Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30 on 2010-01-12. The reason FDA records is "When turned on, the Neptune heater may cause an artifact on the patient's heart monitor". 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-1040-2010
Status: Terminated
Initiated: 2010-01-12
Posted: 2010-03-09
Terminated: 2011-04-05
Recalling firm: Teleflex Medical
Product: Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.
Quantity in commerce: 15,134 units
Distribution: U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
Product codes and lots: Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.

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)