—#110106

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.

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K063758
Affected lot / code info: Catalog #425-00, 425-10 and 425-30.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.

Timeline

Recall initiated: 2012-06-12
Posted by FDA: 2012-07-19
Terminated: 2014-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.