Vortex CT Port Access System and Lifeguard Safety Infusion Set

• • Terminated Z-1466-2021 FDA Class II ·initiated 22 Feb 2021

  AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

• • Terminated Z-0056-2012 FDA Unclassified (pre-2012) ·initiated 1 Aug 2011 ·on shared 510(k) K062414

  The product may contain an incorrect size catheter and introducer.

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

510(k) Number

K062414 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vortex Ez Vascular Access Port

  Class II

  FDA 510(k) K050176 Active Cleared 25 Feb 2005

• Omnipicc Pi

  Class II

  FDA 510(k) K051102 Active Cleared 23 Nov 2005

• Rita Rf Generator and Accessories, Model 500 Series

  Class II

  FDA 510(k) K983214 Active Cleared 27 Mar 2000

• Rita Model 1500X Electrosurgical Rf Generator

  Class II

  FDA 510(k) K031257 Active Cleared 2 May 2003

• Rita System

  Class II

  FDA 510(k) K021329 Active Cleared 9 Oct 2002

• Omnipicc P.I.

  Class II

  FDA 510(k) K062579 Active Cleared 28 Nov 2006

See all devices from Rita Medical Systems, Inc. →