Dic Tracheostomy Tube and Portex Blue Line

• 2 recalls, same reason

  • Terminated Z-0228-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004 ·on shared 510(k) K934465
  • Terminated Z-0229-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004 ·on shared 510(k) K934465

  Sterility of the device is compromised due to packaging defects

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K934465 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Tracheostomy Kit

  Class II

  FDA 510(k) K936133 Active Cleared 23 Mar 1994

• Pro-Vent(Tm), Pulsator(R), and Line Draw(Tm) Arterial Blood Sampling Syringes

  Class II

  FDA 510(k) K945777 Active Cleared 22 Dec 1994

• Sims Cpap System

  Class II

  FDA 510(k) K953485 Active Cleared 26 Oct 1995

• Regional Anesthesia Trays Open recall

  Class II

  FDA 510(k) K965017 Active Cleared 14 Mar 1997

• Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

  Class II

  FDA 510(k) K972385 Active Cleared 20 Jan 1998

• Pro-Vent, Line Draw, Pulsator Open recall

  Class II

  FDA 510(k) K952516 Active Cleared 14 Jul 1995

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