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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ureteral, general & plastic surgery
Regulation Description Urological catheter and accessories.
Product CodeGBL
Regulation Number 876.5130
Device Class 2

Device Problems
Material separation 28
Device, removal of (non-implant) 5
Break 5
Material fragmentation 3
Tip breakage 3
Flaked 2
Device, or device fragments remain in patient 1
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
No code available 1
Total Device Problems 50

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Aug-22-2016

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