Recall Z-1558-2015— Teleflex Medical

Name: FDA recall Z-1558-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-01

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2015-04-01, terminated 2025-03-05. It names one FDA 510(k) clearance: K131912. Product: Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.. Reason: Customer complaints were received of power to the unit ceasing and the display going blank..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2015-04-01
Terminated: 2025-03-05
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMNTeleflex, Inc.·cleared 2014-03-06

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

Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.

Reason for recall

Customer complaints were received of power to the unit ceasing and the display going blank.

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