Lifeguard Safety Infusion Set

• • Terminated Z-0679-2018 FDA Class II ·initiated 24 Jul 2017

  Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

• • Terminated Z-0914-2013 FDA Class II ·initiated 21 Jan 2013

  The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.

• • Terminated Z-1327-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010

  Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

510(k) Number

K013871 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Hmp Titanium Low Profile Port

  Class II

  FDA 510(k) K934573 Active Cleared 25 Feb 1994

• Triumph Vtx with Lifevalve Catheter

  Class II

  FDA 510(k) K032557 Active Cleared 9 Sep 2003

• Lifevalve Central Venous Cathter

  Class II

  FDA 510(k) K031718 Active Cleared 2 Jul 2003

• Hmp Dual Titanium Port

  Class II

  FDA 510(k) K934504 Active Cleared 25 Feb 1994

• Super C Hemodialysis/Apheresis Chronic Catheter, Model Dc-36 Series, Dc-40 Series, Dc-45 Series

  Class II

  FDA 510(k) K011916 Active Cleared 31 Oct 2001

• Hmp Titanium Port

  Class II

  FDA 510(k) K933990 Active Cleared 25 Feb 1994

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