Recall Z-1115-2020— TELEFLEX MEDICAL INC

Name: FDA recall Z-1115-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-13

Class I · Terminated

Class I FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2019-12-13, terminated 2024-04-30. It names one FDA 510(k) clearance: K131912. Product: HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit. Reason: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy..

Recalling firm: TELEFLEX MEDICAL INC
Classification: Class I
Status: Terminated
Initiated: 2019-12-13
Terminated: 2024-04-30
Firm location: Morrisville, 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

HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit

Reason for recall

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

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