Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless

• 2 recalls, same reason

  • Terminated Z-2695-2011 FDA Unclassified (pre-2012) ·initiated 4 Apr 2011
  • Terminated Z-2697-2011 FDA Unclassified (pre-2012) ·initiated 4 Apr 2011

  Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.

510(k) Number

K023918 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Epidural Catheter Models 1210/1200

  Class II

  FDA 510(k) K983125 Active Cleared 17 Nov 1998

• Flocath

  Class II

  FDA 510(k) K000070 Active Cleared 18 Feb 2000

• Intermittent Urethral Catheters

  Class II

  FDA 510(k) K033023 Active Cleared 23 Dec 2003

• Rusch Miller-Abbott Tube

  Class II

  FDA 510(k) K010797 Active Cleared 26 Feb 2002

• Rusch Floneil; Flocath Introgel

  Class II

  FDA 510(k) K020714 Active Cleared 1 Jul 2002

• Rusch Schroeder Endotracheal Tube Style

  Class I

  FDA 510(k) K955238 Active Cleared 6 Feb 1996

See all devices from Rusch Intl. →