Per-Fit Percutaneous Dilational Tracheostomy Kit

• • Terminated Z-0100-2008 FDA Unclassified (pre-2012) ·initiated 18 Sep 2007

  Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

• 6 recalls, same reason

  • Terminated Z-0872-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005
  • Terminated Z-0871-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005
  • Terminated Z-0868-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005
  • Terminated Z-0869-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005
  • Terminated Z-0870-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005
  • Terminated Z-0867-05 FDA Unclassified (pre-2012) ·initiated 16 May 2005

  Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

510(k) Number

K031057 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Trocar Catheter/Thoracic Catheter

  Class II

  FDA 510(k) K792202 Active Cleared 20 Nov 1979

• Thermovent 600, 1200, T, 02

  Class I

  FDA 510(k) K874597 Active Cleared 19 Jan 1988

• Blue Line Ultra Suctionaid Tracheostomy Tube

  Class II

  FDA 510(k) K030570 Active Cleared 17 Sep 2003

• Jet Ventilation Adaptor

  Not classified

  FDA 510(k) K842456 Active Cleared 6 Jul 1984

• 1ST Response Intermediate Manual Resuscitator

  Class II

  FDA 510(k) K023793 Active Cleared 11 Feb 2003

• Reinforced Silicone Tracheal Tube

  Class II

  FDA 510(k) K830352 Active Cleared 8 Mar 1983

See all devices from Portex, Ltd. →