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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, catheter, foley (excludes hiv testing)
Regulation Description Urological catheter and accessories.
Definition Foley Catheter Kit (Excludes HIV Testing)
Product CodeNWR
Regulation Number 876.5130
Device Class 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Customed, Inc I Dec-16-2014
4 Customed, Inc I Aug-29-2014

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