Kendall Sher-I-Bronch Endobrochial Tube

• • Terminated Z-2367-2015 FDA Class I ·initiated 1 Jun 2015

  The double swivel connector may crack or separate on the endobronchial tube.

• • Terminated Z-0125-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006 ·on shared 510(k) K961977

  Biological indicator failed. Investigation eliminated all equipment and product related factors.

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

510(k) Number

K961977 ↗

FDA Product Code

CBI

Device Class

Class II

Regulation

21 CFR Part 868.5740

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Curity Vented Dressing System

  Unclassified

  FDA 510(k) K915635 Active Cleared 31 Jan 1992

• Kendall Safetrak Combined Epidural/Spinal Kit

  Class II

  FDA 510(k) K941493 Active Cleared 22 Jun 1994

• Kendall Universal Extension Set

  Class I

  FDA 510(k) K930551 Active Cleared 12 May 1993

• Kendall Home Rx Therapeutic Stocking

  Class II

  FDA 510(k) K925417 Active Cleared 4 Jun 1993

• Curad Kid Size Instant Cold Pack

  Class I

  FDA 510(k) K920252 Active Cleared 11 Feb 1992

• Curity(R) Calib Tuohy Type Epidur Needle Fix Wing

  Class II

  FDA 510(k) K910791 Active Cleared 17 May 1991

See all devices from Kendall Healthcare Products Co. Div.Of Tyco Health →