Trimport Implantable Access System (Modification)

• 7 recalls, same reason

  • Terminated Z-1884-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1886-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1885-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1887-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1881-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1883-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1882-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010

  FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.

• • Terminated Z-0745-2007 FDA Unclassified (pre-2012) ·initiated 13 Jun 2006

  Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)

• • Terminated Z-0746-2007 FDA Unclassified (pre-2012) ·initiated 13 Jun 2006

  Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)

• • Terminated Z-0340-06 FDA Unclassified (pre-2012) ·initiated 28 Oct 2005 ·on shared 510(k) K954258

  Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

• 2 recalls, same reason

  • Terminated Z-1481-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K954258
  • Terminated Z-1476-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K954258

  The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

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

510(k) Number

K954258 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Dual Plastic Vascular Access System

  Class II

  FDA 510(k) K922147 Active Cleared 4 Dec 1992

• Gerard Medical, Inc. Trim-Port

  Class II

  FDA 510(k) K903364 Active Cleared 31 Oct 1990

• Modified Version Implantable Vascular Access Syste

  Class II

  FDA 510(k) K912111 Active Cleared 8 Oct 1991

• Trimport

  Class II

  FDA 510(k) K942623 Active Cleared 23 Aug 1994

• Trim-Port(Tm) Implant Access Syst Dual Titan Port

  Class II

  FDA 510(k) K913114 Active Cleared 2 Jan 1992

• Gerard Medical Electrode Tester

  Class II

  FDA 510(k) K813358 Active Cleared 29 Dec 1981

See all devices from Gerard Medical Enterprises, Inc. →