30 IV Extension Set W/Two Male Luer Locks

• • Terminated Z-0933-2018 FDA Class II ·initiated 3 Oct 2017 ·on shared 510(k) K882503

  The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

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

510(k) Number

K882503 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Churchill Medical Systems Stopcock

  Class II

  FDA 510(k) K012157 Active Cleared 11 Sep 2001

• 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

See all devices from Churchill Medical Systems, Inc. →