Therex Low-Profile Port Detached Catheter System

• • Terminated Z-0280-2007 FDA Unclassified (pre-2012) ·initiated 29 Sep 2006

  Catheter has separated from the infusion port body.

• 4 recalls, same reason

  • Terminated Z-0254-04 FDA Unclassified (pre-2012) ·initiated 4 Nov 2003 ·on shared 510(k) K933316
  • Terminated Z-0256-04 FDA Unclassified (pre-2012) ·initiated 4 Nov 2003 ·on shared 510(k) K933316
  • Terminated Z-0255-04 FDA Unclassified (pre-2012) ·initiated 4 Nov 2003 ·on shared 510(k) K933316
  • Terminated Z-0257-04 FDA Unclassified (pre-2012) ·initiated 4 Nov 2003 ·on shared 510(k) K933316

  The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

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

510(k) Number

K933316 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Non-Corning (Huber) Needle

  Class II

  FDA 510(k) K936029 Active Cleared 4 Feb 1994

• A-Port Implant Vasc Access Syst Line Ext-A2 Port

  Class II

  FDA 510(k) K911055 Active Cleared 19 Apr 1991

• Therex Low-Profile Port 1.5mm I.D. X 2.7mm O.D. Detached Catheter System

  Class II

  FDA 510(k) K933350 Active Cleared 23 Feb 1994

• Low Profile Titanium Model Catalog #1003

  Class II

  FDA 510(k) K953110 Active Cleared 13 Sep 1995

• A Port Implant Vascular Access System - Detached

  Class II

  FDA 510(k) K882230 Active Cleared 29 Jul 1988

• Therex Low-Profile Port - Titanium Model

  Class II

  FDA 510(k) K942412 Active Cleared 19 Aug 1994

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