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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applier, hemostatic clip
Regulation Description Manual surgical instrument for general use.
Product CodeHBT
Regulation Number 878.4800
Device Class 1

Device Problems
Sticking 1
Delivery system failure 1
Device operates differently than expected 1
Dislodged or dislocated 1
Total Device Problems 4

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 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Lemaitre Vascular, Inc. III Oct-28-2010
2 Sterilmed Inc II Jan-13-2009

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