Port-A-Cath Dual Lumen Implantable Venous Access

• • Terminated Z-2269-2013 FDA Class II ·initiated 10 Sep 2013

  Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports

• • Terminated Z-0807-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006 ·on shared 510(k) K932841

  One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.

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

510(k) Number

K932841 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• The Gripper Seal(Tm)

  Class I

  FDA 510(k) K870900 Active Cleared 31 Mar 1987

• Pharmacia Deltec Peripherally Inserted Venous Cath

  Class II

  FDA 510(k) K926544 Active Cleared 21 Mar 1994

• Port-A-Cath Implantable Drug Delivery System

  Class II

  FDA 510(k) K903220 Active Cleared 10 Oct 1990

• Lockbox

  Class II

  FDA 510(k) K900888 Active Cleared 15 May 1990

• Port-A-Cath Implantable Vascular Access System

  Class II

  FDA 510(k) K932840 Active Cleared 5 Jan 1994

• Model 1330 Extension Set

  Class II

  FDA 510(k) K873042 Active Cleared 23 Oct 1987

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