Port-A-Cath- II Dual-Lumen Low Profile System, Port-a-Cath II Dual Lumen Low Profile System with Introducer Set, Port-a

• • Terminated Z-1073-2018 FDA Class II ·initiated 4 Dec 2017

  Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.

• 2 recalls, same reason

  • Terminated Z-0878-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004
  • Terminated Z-0877-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004

  Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

510(k) Number

K974471 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Port-A-Cath P.A.S. Port II Implantable Venous Access Sytems

  Class II

  FDA 510(k) K961580 Active Cleared 20 Sep 1996

• Sims Silo Needle De-Access Enclosure

  Class II

  FDA 510(k) K935767 Active Cleared 15 Nov 1995

• Port-A-Cath II Trans-Arterial Percutaneous System

  Class II

  FDA 510(k) K992697 Active Cleared 18 Nov 1999

• Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter

  Class II

  FDA 510(k) K990083 Active Cleared 12 Feb 1999

• Port-A-Cath Low-Profile Implantable Access Systems

  Class II

  FDA 510(k) K973862 Active Cleared 29 Dec 1997

• Cadd Administration Set

  Class II

  FDA 510(k) K991599 Active Cleared 15 Jun 1999

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