Catheter Connections Dualcap Solo

• • Terminated Z-2595-2014 FDA Class II ·initiated 5 Aug 2014 ·on shared 510(k) K123065

  Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K123065 ↗

FDA Product Code

QBP

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Catheter Connections' Dualcap Solo

  Class II

  FDA 510(k) K113842 Active Cleared 27 Jan 2012

• Catheter Connections' Dualcap Duo

  Class II

  FDA 510(k) K112985 Active Cleared 9 Nov 2011

• Catheter Connections Dualcap

  Class II

  FDA 510(k) K093229 Active Cleared 8 Apr 2010

• DualCap IV Pole Strips (Disinfectant Caps for Male Luers)

  Class II

  FDA 510(k) K142399 Active Cleared 19 Nov 2014

• DualCap

  Class II

  FDA 510(k) K142806 Active Cleared 22 May 2015

• Catheter Connections' Dark Blue Dualcap for Male Luers

  Class II

  FDA 510(k) K123967 Active Cleared 22 Jan 2013