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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tourniquet, pneumatic
Regulation Description Pneumatic tourniquet.
Product CodeKCY
Regulation Number 878.5910
Device Class 1


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 3
Inflation issue 3
Decrease in pressure 2
Material rigid or stiff 2
Device operates differently than expected 2
Material deformation 2
Battery failure 1
Improper or incorrect procedure or method 1
Dissatisfaction 1
Total Device Problems 17

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

Recalls
Manufacturer Recall Class Date Posted
1 Ascent Healthcare Solutions, Inc. II Sep-19-2008
2 Sterilmed Inc II Jan-13-2009
3 Stryker Instruments Div. of Stryker Corporation III Sep-21-2011
4 Stryker Instruments Div. of Stryker Corporation II Jan-18-2011
5 Virtus, Inc. II Jan-23-2009
6 Zimmer, Inc. II Nov-15-2012

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