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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, intravascular catheter securement
Regulation Description Intravascular catheter securement device.
Product CodeKMK
Regulation Number 880.5210
Device Class 1


Premarket Reviews
ManufacturerDecision
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
TAPEMARK CO.
  SUBSTANTIALLY EQUIVALENT 1
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loss of or failure to bond 33
Device disinfection or sterilization issue 10
Delivered as unsterile product 9
No Known Device Problem 7
Failure to Adhere or Bond 3
Use of Device Issue 3
Unsealed device packaging 2
Failure to disinfect 2
Migration of device or device component 1
Detachment of device component 1
Material separation 1
No Information 1
Inadequate user interface 1
Mechanics altered 1
Total Device Problems 75

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

Recalls
Manufacturer Recall Class Date Posted
1 Bard Access Systems II Jun-28-2013
2 Merit Medical Systems, Inc II Mar-15-2007

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