Cadd Administration Set

• 3 recalls, same reason

  • Terminated Z-0660-06 FDA Unclassified (pre-2012) ·initiated 8 Dec 2005
  • Terminated Z-0659-06 FDA Unclassified (pre-2012) ·initiated 8 Dec 2005
  • Terminated Z-0658-06 FDA Unclassified (pre-2012) ·initiated 8 Dec 2005

  Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

• 29 recalls, same reason

  • Terminated Z-0488-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0469-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0476-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0472-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0465-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0470-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0491-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0467-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0473-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0487-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0484-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0489-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0471-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0481-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0474-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0478-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0485-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0483-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0486-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0466-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0479-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0468-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0475-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0477-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0492-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0482-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0464-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0490-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004
  • Terminated Z-0480-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004

  Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..

510(k) Number

K991599 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Port-A-Cath P.A.S. Port II Implantable Venous Access Sytems

  Class II

  FDA 510(k) K961580 Active Cleared 20 Sep 1996

• Sims Silo Needle De-Access Enclosure

  Class II

  FDA 510(k) K935767 Active Cleared 15 Nov 1995

• Port-A-Cath II Trans-Arterial Percutaneous System

  Class II

  FDA 510(k) K992697 Active Cleared 18 Nov 1999

• Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter

  Class II

  FDA 510(k) K990083 Active Cleared 12 Feb 1999

• Port-A-Cath Low-Profile Implantable Access Systems

  Class II

  FDA 510(k) K973862 Active Cleared 29 Dec 1997

• Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1

  Class II

  FDA 510(k) K991301 Active Cleared 9 Jun 1999

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