Bivona Hyperflex Tracheostomy Tube

• 3 recalls, same reason

  • Terminated Z-0395-06 FDA Unclassified (pre-2012) ·initiated 16 Dec 2005
  • Terminated Z-0394-06 FDA Unclassified (pre-2012) ·initiated 16 Dec 2005
  • Terminated Z-0396-06 FDA Unclassified (pre-2012) ·initiated 16 Dec 2005

  Sterility is compromised by incomplete package seal.

• • Terminated Z-0338-06 FDA Unclassified (pre-2012) ·initiated 19 Apr 2005 ·on shared 510(k) K922665

  The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

• • Terminated Z-0927-03 FDA Unclassified (pre-2012) ·initiated 20 Feb 2003 ·on shared 510(k) K922665

  May have incorrectly printed graduation markings along the tube shaft.

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

510(k) Number

K922665 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

  Class II

  FDA 510(k) K792035 Active Cleared 26 Oct 1979

• Aire-Cuf Polyester Re-Enforced Endotracheal Tube

  Class II

  FDA 510(k) K872366 Active Cleared 17 Aug 1987

• Fome-Cuf Pvc

  Class II

  FDA 510(k) K780583 Active Cleared 12 May 1978

• Fome-Cuf and Aire Cuf Tracheostomy Tubes

  Class II

  FDA 510(k) K862267 Active Cleared 18 Jun 1986

• Bivona Nasal Turbinate Stent

  Class I

  FDA 510(k) K935053 Active Cleared 1 Jul 1994

• Bivona Carden Intermittent Jetting Device

  Class II

  FDA 510(k) K895946 Active Cleared 9 Jan 1990

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