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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, delivery, allergen and vaccine
Product CodeLDH
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fracture 1
Material integrity issue 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Allergy Laboratories, Inc. II Sep-12-2016
2 Medscience Inc II May-31-2016

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