Low Plasticizer Administration Sets

• 3 recalls, same reason

  • Terminated Z-0629-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0626-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-1424-05 FDA Unclassified (pre-2012) ·initiated 3 Aug 2005

  The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

• • Terminated Z-1103-05 FDA Unclassified (pre-2012) ·initiated 6 Jul 2005

  Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.

• • Terminated Z-0854-05 FDA Unclassified (pre-2012) ·initiated 3 Mar 2005

  Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.

• • Terminated Z-0845-05 FDA Unclassified (pre-2012) ·initiated 28 Feb 2005

  Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

• • Terminated Z-0694-05 FDA Unclassified (pre-2012) ·initiated 20 Jan 2005

  Product older than three years may not operate as intended.

• 5 recalls, same reason

  • Terminated Z-0519-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0520-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0521-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0517-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0518-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002

  The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

510(k) Number

K791496 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

• Arteoial Blood Sampling Kit 2D9014

  Class II

  FDA 510(k) K771584 Active Cleared 13 Sep 1977

• Blood-Solution Administration Set, Surg.

  Class I

  FDA 510(k) K760483 Active Cleared 3 Sep 1976

• Flo-Gard 8000 Computer Control Infusi

  Class II

  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →