Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column

• 2 recalls, same reason

  • Terminated Z-1114-2020 FDA Class I ·initiated 13 Dec 2019
  • Terminated Z-1115-2020 FDA Class I ·initiated 13 Dec 2019

  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.

• • Terminated Z-1558-2015 FDA Class II ·initiated 1 Apr 2015

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

510(k) Number

K131912 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Introducer Kit

  Class II

  FDA 510(k) K123974 Active Cleared 21 Feb 2013

• Conchasmart Breathing Circuit

  Class II

  FDA 510(k) K140556 Active Cleared 24 Sep 2014

• ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set

  Class II

  FDA 510(k) K153652 Active Cleared 21 Jun 2016

• Peel Away & Split Sheath Percu Cath Introducer Set

  Class II

  FDA 510(k) K860307 Active Cleared 20 May 1986

• Conchasmart Column

  Class II

  FDA 510(k) K141940 Active Cleared 24 Nov 2014

• Modified Teleflex Medical Introducer Catheter

  Class II

  FDA 510(k) K861951 Active Cleared 19 Jun 1986

See all devices from Teleflex LLC →