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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device introducer, syringe needle
Regulation Description Syringe needle introducer.
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
ANIMAS
  SUBSTANTIALLY EQUIVALENT 1
DERMOEQUIPOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL HOUSE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
OWEN MUMFORD
  SUBSTANTIALLY EQUIVALENT 2
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
PHARMA-PEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDINAVIAN HEALTH, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Misfire 46
Unintended ejection 35
Product quality issue 1
Break 1
Connection issue 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 86

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

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Nov-07-2011
2 Owen Mumford USA, Inc. II Apr-02-2015

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