Low Profile Tracheostomy Tube

• 2 recalls, same reason

  • Terminated Z-0228-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0229-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004

  Sterility of the device is compromised due to packaging defects

• • Terminated Z-1039-03 FDA Unclassified (pre-2012) ·initiated 18 Jun 2003

  Mislabeled:Tracheostomy tube was not fenestrated as specified on the label

510(k) Number

K922749 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Suction Control Valve

  Class I

  FDA 510(k) K892343 Active Cleared 24 Apr 1989

• Accu-Vent(Tm) with Needle-Pro(Tm)

  Class I

  FDA 510(k) K912043 Active Cleared 5 Jul 1991

• Needle-Pro Cartridge

  Class II

  FDA 510(k) K923127 Active Cleared 29 Apr 1993

• Subcutaneous Tunneling Needle and Handles

  Class II

  FDA 510(k) K930218 Active Cleared 27 Jul 1993

• Heat Moisture Condenser

  Class I

  FDA 510(k) K923910 Active Cleared 26 Jan 1993

• Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K915452 Active Cleared 14 Feb 1992

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