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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dispenser, liquid medication
Regulation Description Liquid medication dispenser.
Product CodeKYX
Regulation Number 880.6430
Device Class 1


Premarket Reviews
ManufacturerDecision
SANGSTAT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Underdelivery 2
Component(s), broken 1
Syringe markings inaccurate 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 2 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Corporation Englewood II Feb-27-2015
2 Baxter Corporation Englewood II Dec-24-2014
3 Becton Dickinson & Company III Feb-23-2012
4 Benlan, Inc. III Feb-21-2012

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