Curity I.V. Start Kit

• • Terminated Z-1303-2013 FDA Class III ·initiated 12 Apr 2013

  On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

510(k) Number

K842898 ↗

FDA Product Code

LRS

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Curity Venous Catheterization Kit

  Class II

  FDA 510(k) K861828 Active Cleared 10 Jul 1986

• Curity Fiberoptic Intubating Airway

  Class I

  FDA 510(k) K855137 Active Cleared 11 Mar 1986

• Curity Curad Bandages

  Class I

  FDA 510(k) K810126 Active Cleared 6 Feb 1981

• The Kendall Urinary Output Monitor

  Class I

  FDA 510(k) K852083 Active Cleared 20 Sep 1985

• Kendall Curity Irrigation Syringe

  Class II

  FDA 510(k) K892436 Active Cleared 14 Jul 1989

• Curity Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K871066 Active Cleared 15 May 1987

See all devices from The Kendal Co. →