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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, nephrostomy, general & plastic surgery
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBO
Regulation Number 878.4200
Device Class 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 19
Material separation 9
Unknown (for use when the device problem is not known) 3
Break 3
Component(s), broken 2
Fracture 2
Hole in material 1
Migration of device or device component 1
Difficult to remove 1
Sterility 1
Suture line separation 1
Tip breakage 1
Wire(s), breakage of 1
Device Issue 1
Tear, rip or hole in device packaging 1
Cut in material 1
Device, removal of (non-implant) 1
Dislodged or dislocated 1
Detachment of device component 1
Total Device Problems 51

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-21-2009

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