Smartsite Needle Free Valve Administration Sets

• 2 recalls, same reason

  • Ongoing Z-2454-2021 FDA Class II ·initiated 2 Aug 2021
  • Ongoing Z-2455-2021 FDA Class II ·initiated 2 Aug 2021

  Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

510(k) Number

K061285 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

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

• Se Infusion System with Mms

  Class II

  FDA 510(k) K043590 Active Cleared 25 Mar 2005

See all devices from Cardinal Health, Alaris Products →