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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sealant,polymerizing
Product CodeNBE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
4 4 2 10 6 12 10 4 7 3

Device Problems
Foreign material present in device 25
Device clogged 5
Improper or incorrect procedure or method 4
Break 3
Crack 2
Migration of device or device component 1
Blockage within device or device component 1
Obstruction within device 1
Device displays error message 1
Device operates differently than expected 1
Improper device output 1
Total Device Problems 45

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 1 0 2 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Bioscience II Jul-02-2010
2 Baxter Healthcare Corp II May-31-2016
3 Baxter Healthcare Services L.P. II May-16-2012
4 Neomend Inc II Sep-25-2012

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