Gerard Medical, Inc. Trim-Port

• 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-1882-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1883-2010 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-1479-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K903364

  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

K903364 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Dual Plastic Vascular Access System

  Class II

  FDA 510(k) K922147 Active Cleared 4 Dec 1992

• 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

• Trimport Implantable Access System (Modification)

  Class II

  FDA 510(k) K954258 Active Cleared 24 May 1996

See all devices from Gerard Medical Enterprises, Inc. →