Bivona Flextend Pediatric & Neonatal Tracheostromy Tubes

• • Terminated Z-1145-2021 FDA Class II ·initiated 18 Jan 2021

  Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.

• • Terminated Z-0726-2021 FDA Class II ·initiated 15 Dec 2020

  A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

510(k) Number

K944178 ↗

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

See all devices from Bivona Medical Technologies →