FDA Medical Device Recalls (openFDA)
Telefelx Medical: Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
- Recall number
- Z-1040-2010
- Recalling firm
- Telefelx Medical
- Product
- Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
- Status
- Terminated
- Initiated
- 2010-01-12
- Posted
- 2010-03-09
- Terminated
- 2011-04-05
- Reason
- When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
- 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
- 15,134 units
- Distribution
- U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
- Lot, serial or model codes
- Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
- 510(k) numbers
- ["K063758"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28