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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system/device, pharmacy compounding
Regulation Description Intravascular administration set.
Product CodeNEP
Regulation Number 880.5440
Device Class 2

Device Problems
Use of Device Issue 13
Material separation 6
Infusion or flow issue 4
Device operates differently than expected 3
Improper or incorrect procedure or method 3
Device displays error message 2
Underdelivery 1
Volume accuracy issue 1
Disconnection 1
Leak 1
Loss of power 1
Material integrity issue 1
Total Device Problems 37

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 0 0 1 0 1 0 0
Class II 0 1 0 0 0 3 1 1 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxa Corporation II Oct-25-2012
2 Baxa Corporation II Apr-09-2012
3 Baxa Corporation II Apr-05-2012
4 Baxa Corporation II Aug-19-2008
5 Baxa Corporation I Sep-27-2007
6 Baxter Corporation Englewood II May-18-2015
7 Baxter Corporation Englewood II Jun-22-2014
8 Baxter Corporation Englewood I May-12-2014
9 Baxter Healthcare Corp. II Jan-07-2016
10 Baxter Healthcare Corp. II Dec-29-2013
11 Baxter Healthcare Corp. I Aug-08-2012
12 ICU Medical, Inc. II Apr-11-2016

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