FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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.
- Recall number
- Z-2036-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-06-12
- Posted
- 2012-07-19
- Terminated
- 2014-01-28
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Catalog #425-00, 425-10 and 425-30.
- 510(k) numbers
- ["K063758"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- 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