Radiation Sterilized Admin. Set

• • Terminated Z-1268-2013 FDA Class II ·initiated 28 Mar 2013

  Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

• • Terminated Z-0149-2011 FDA Unclassified (pre-2012) ·initiated 9 Sep 2010

  During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.

• 7 recalls, same reason

  • Terminated Z-0635-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0628-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0649-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0645-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0627-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0646-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005 ·on shared 510(k) K811078
  • Terminated Z-0639-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 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-1101-05 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.

• 7 recalls, same reason

  • Terminated Z-0506-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0515-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0516-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0514-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0511-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0512-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002
  • Terminated Z-0513-03 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.

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

510(k) Number

K811078 ↗

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. →