Suture Removal Kit

• • Terminated Z-1304-2013 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

K761193 ↗

FDA Product Code

KDD

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Tracheostomy Care Kit Open recall

  Class II

  FDA 510(k) K761190 Active Cleared 16 Dec 1976

• 3.5 & 5.5 Oz. Sodium Chloride Solution

  Class II

  FDA 510(k) K820460 Active Cleared 8 Mar 1982

• Enteral Feeding Bottle

  Class II

  FDA 510(k) K841945 Active Cleared 26 Jul 1984

• 9 French 42LONG Polyurethane Graduated Enteric Fe

  Class II

  FDA 510(k) K843975 Active Cleared 20 Nov 1984

• Dispos. Enteric Feeding Tubes W/Safe-T

  Class II

  FDA 510(k) K833687 Active Cleared 2 Mar 1984

• Enteral Nutrition Pump

  Class II

  FDA 510(k) K841630 Active Cleared 7 Jun 1984

See all devices from Superior Plastic Products Corp. →