Portex Adjustable Flange Tracheostomy Tube

• • Terminated Z-3213-2017 FDA Class II ·initiated 14 Aug 2017

  Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.

510(k) Number

K962175 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

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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