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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device razor, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLWK
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 12
Cut in material 2
Sharp/jagged/rough/etched/scratched 2
Difficult to remove 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 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 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Aug-20-2015

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