Valleylab Model E252OH, Force Gsu(Tm) Handset

• 25 recalls, same reason

  • Terminated Z-2559-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2560-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2578-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2555-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2557-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2554-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2563-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2565-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2562-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2556-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2564-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2570-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2568-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2561-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2571-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2576-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2575-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2574-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2569-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2567-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2573-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2566-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2572-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2558-2016 FDA Class II ·initiated 8 Jul 2016
  • Terminated Z-2577-2016 FDA Class II ·initiated 8 Jul 2016

  Potential for compromise of the package resulting in a breach of the sterile barrier

510(k) Number

K926481 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Models E2502B/E2525 Reusable Handswitching Pencils

  Class II

  FDA 510(k) K914400 Active Cleared 17 Oct 1991

• Cusa System 200C, T & M Ultrasonic Surgical Aspira.

  Unclassified

  FDA 510(k) K884412 Active Cleared 2 Dec 1988

• Valleylab Procision(Tm) System

  Class II

  FDA 510(k) K945688 Active Cleared 13 Jun 1995

• Ligasure 5mm Blunt Tip Laparoscopic Sealer-Divider

  Class II

  FDA 510(k) K092879 Active Cleared 16 Oct 2009

• Davis Bayonet Electrodes

  Class II

  FDA 510(k) K964602 Active Cleared 9 Jan 1997

• Force Gsu System Model No. Gsu-20 and Gsu-22

  Class II

  FDA 510(k) K942579 Active Cleared 21 Sep 1994

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