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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applicator, absorbent tipped, sterile
Regulation Description Absorbent tipped applicator.
Product CodeKXG
Regulation Number 880.6025
Device Class 1

Device Problems
Detachment of device or device component 7
Break 4
Detachment of device component 2
Material separation 2
Unraveled material 1
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
Loss of or failure to bond 1
Total Device Problems 19

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

Recalls
Manufacturer Recall Class Date Posted
1 Fisher Scientific Co II Apr-28-2014
2 Fisher Scientific Co II Aug-12-2013
3 Puritan Medical Products Co., LLC II Mar-13-2015

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