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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bandage, elastic
Regulation Description Elastic bandage.
Product CodeFQM
Regulation Number 880.5075
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
Device operates differently than expected 2
Human-Device Interface Issue 1
Loss of or failure to bond 1
Material frayed 1
Instruction for use issue 1
User used incorrect product for intended use 1
Total Device Problems 12

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

Recalls
Manufacturer Recall Class Date Posted
1 Afassco Inc II Aug-08-2012
2 Cardinal Health II Jan-16-2009
3 Medline Industries Inc II May-21-2014

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