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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, photopheresis, extracorporeal
Product CodeLNR
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 3 4 1 7 5 7 2 5 5

Device Problems
No Known Device Problem 32
Leak 30
Device displays error message 29
Fluid leak 24
Break 15
Air leak 7
Device alarm system issue 4
Noise, Audible 4
No Information 2
Malposition of device 2
Split 2
Free or unrestricted flow 2
Fracture 2
Hole in material 2
Loose or intermittent connection 2
Occlusion within device 2
Increase in pressure 1
Difficult to remove 1
Stretched 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Defective component 1
Device contamination with blood or blood product 1
Obstruction within device 1
Lens washers, failure of 1
Bent 1
Crack 1
Disconnection 1
Dislodged or dislocated 1
Total Device Problems 174

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 3 1 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Therakos Inc II Apr-05-2016
2 Therakos Inc II Jul-19-2011
3 Therakos Inc II Apr-28-2011
4 Therakos Inc II May-26-2010
5 Therakos, Inc. II Jan-11-2012
6 Therakos, Inc. II Aug-10-2011

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