Alaris Safety Male Luer

• 2 recalls, same reason

  • Ongoing Z-1970-2025 FDA Class II ·initiated 12 May 2025
  • Ongoing Z-1973-2025 FDA Class II ·initiated 12 May 2025

  Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

• • Terminated Z-0218-2008 FDA Unclassified (pre-2012) ·initiated 30 Aug 2007

  Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)

510(k) Number

K053049 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 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

• 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 →