Se Infusion System with Mms

• • Terminated Z-1484-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006

  This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

510(k) Number

K043590 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Alaris Safety Male Luer Open recall

  Class II

  FDA 510(k) K053049 Active Cleared 12 Jan 2006

• Turbo Temp Trio

  Class II

  FDA 510(k) K050230 Active Cleared 16 Feb 2005

• Blood Hand Pump Administration Set

  Class II

  FDA 510(k) K050115 Active Cleared 1 Apr 2005

• Alaris System Pc Unit, Model 8001 Open recall

  Class II

  FDA 510(k) K051641 Active Cleared 20 Oct 2005

• Smartsite Vented Vial Access Device, Model Tbd

  Class II

  FDA 510(k) K052790 Active Cleared 23 Dec 2005

• Smartsite Needle Free Valve Administration Sets Open recall

  Class II

  FDA 510(k) K061285 Active Cleared 26 Jul 2006

See all devices from Cardinal Health, Alaris Products →