Modification to 30 Extension Set

• • Terminated Z-1484-2017 FDA Class II ·initiated 20 Feb 2017

  Incorrect priming volume printed on the device package.

• • Terminated Z-0787-2017 FDA Class II ·initiated 18 Nov 2016

  Incorrect priming volume is printed on the device package.

• 12 recalls, same reason

  • Terminated Z-1467-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1477-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1470-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1468-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1478-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1474-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1475-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1476-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1473-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1469-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1471-2015 FDA Class II ·initiated 15 Jan 2015
  • Terminated Z-1472-2015 FDA Class II ·initiated 15 Jan 2015

  Potential for leaking caused by insufficient bond between needleless device and female luer.

• • Terminated Z-0813-2014 FDA Class II ·initiated 7 Jan 2014

  Defective component may cause extension sets to leak.

• 3 recalls, same reason

  • Terminated Z-1326-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1330-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1325-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010

  Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

510(k) Number

K021395 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 30 IV Extension Set W/Two Male Luer Locks

  Class II

  FDA 510(k) K882503 Active Cleared 25 Aug 1988

• Churchill Medical Systems Stopcock

  Class II

  FDA 510(k) K012157 Active Cleared 11 Sep 2001

• Cms IV Filters

  Class II

  FDA 510(k) K896333 Active Cleared 11 Jan 1990

• Universal Vial Access Spike with Needleless Connector

  Class II

  FDA 510(k) K013949 Active Cleared 27 Mar 2002

• CMS IV Extension Sets

  Class II

  FDA 510(k) K884370 Active Cleared 7 Nov 1988

• Primary Solution Set With Universal Spike, Injection Site And Male Luer Lock

  Class II

  FDA 510(k) K011336 Active Cleared 12 Jun 2001

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