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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, noninvasive
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeGAZ
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Defective item 4
Fluid leak 1
Other (for use when an appropriate device code cannot be identified) 1
Disconnection 1
Material fragmentation 1
Total Device Problems 8

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

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Sep-22-2010
2 Mentor Texas, Inc II Dec-12-2008

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