Pharmacia Deltec Subclavian Introducers

• • Terminated Z-2268-2013 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-0066-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006 ·on shared 510(k) K871132

  Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

• 4 recalls, same reason

  • Terminated Z-0804-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006 ·on shared 510(k) K871132
  • Terminated Z-0801-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006 ·on shared 510(k) K871132
  • Terminated Z-0807-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006 ·on shared 510(k) K871132
  • Terminated Z-0800-06 FDA Unclassified (pre-2012) ·initiated 29 Mar 2006 ·on shared 510(k) K871132

  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

K871132 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cadd-Vt, 5300 Ambulatory Infusion Pump W/3050, 50M

  Class II

  FDA 510(k) K850183 Active Cleared 13 Mar 1985

• Cadd-1, Model 5100 Hf, Ambulatory Infusion Pump

  Class II

  FDA 510(k) K853584 Active Cleared 12 Nov 1985

• Ac Adapter Accessory, Product Code 600123A

  Class II

  FDA 510(k) K870768 Active Cleared 13 Mar 1987

• Cadd-1, Model 5100 Hf

  Class II

  FDA 510(k) K862927 Active Cleared 27 Aug 1986

• CADD-1 5100 Ambulatory Infusion Pump

  Class II

  FDA 510(k) K843772 Active Cleared 6 Dec 1984

• Cadd-Pac 5200 Ambulatory Infusion Pump

  Class II

  FDA 510(k) K843773 Active Cleared 6 Dec 1984

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