Churchill Medical Systems Stopcock

• • Terminated Z-0682-2018 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.

510(k) Number

K012157 ↗

FDA Product Code

FMG

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 30 IV Extension Set W/Two Male Luer Locks

  Class II

  FDA 510(k) K882503 Active Cleared 25 Aug 1988

• Cms IV Filters

  Class II

  FDA 510(k) K896333 Active Cleared 11 Jan 1990

• Universal Vial Access Spike with Needleless Connector

  Class II

  FDA 510(k) K013949 Active Cleared 27 Mar 2002

• CMS IV Extension Sets

  Class II

  FDA 510(k) K884370 Active Cleared 7 Nov 1988

• Modification to 30 Extension Set

  Class II

  FDA 510(k) K021395 Active Cleared 13 May 2002

• Primary Solution Set With Universal Spike, Injection Site And Male Luer Lock

  Class II

  FDA 510(k) K011336 Active Cleared 12 Jun 2001

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