Recall Z-2036-2012— Teleflex Medical

Name: FDA recall Z-2036-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2012-06-12, terminated 2014-01-28. It names one FDA 510(k) clearance: K063758. 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.. 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..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Terminated: 2014-01-28
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K063758 — CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00RTeleflex Medical·cleared 2007-04-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.