Modification to IV Spike

• • Terminated Z-2166-2013 FDA Class II ·initiated 5 Aug 2013 ·on shared 510(k) K921860

  Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.

• 5 recalls, same reason

  • Terminated Z-2414-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008
  • Terminated Z-2408-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008 ·on shared 510(k) K921860
  • Terminated Z-2407-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008 ·on shared 510(k) K921860
  • Terminated Z-2409-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008 ·on shared 510(k) K921860
  • Terminated Z-2411-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008

  incorrect burette was packaged with the product

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

510(k) Number

K921860 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Safeline System Turn Lock Cannula

  Class II

  FDA 510(k) K941244 Active Cleared 29 Nov 1994

• Horizon Pump Y-Type Blood Set Open recall

  Class II

  FDA 510(k) K922637 Active Cleared 4 Jun 1993

• Tpn Fluid Transfer Set

  Class II

  FDA 510(k) K905201 Active Cleared 2 Jan 1991

• Intravascular Administration Set

  Class II

  FDA 510(k) K932165 Active Cleared 13 Apr 1994

• Millennium Crt Infusion Pump and Millennium Crt Infusion Pump Administration Sets

  Class II

  FDA 510(k) K972678 Active Cleared 7 Oct 1997

• Intervascular Adminstration Set

  Class II

  FDA 510(k) K911753 Active Cleared 24 Jun 1991

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