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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeKGZ
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 51
Leak 13
Air leak 9
Failure to Adhere or Bond 7
Difficult to remove 6
Unraveled material 6
Material separation 5
Break 4
Detachment of device component 4
Disconnection 4
Stretched 3
Material frayed 2
Crack 2
Loss of or failure to bond 2
Detachment of device or device component 2
Device operates differently than expected 2
Human-Device Interface Issue 2
No Known Device Problem 1
No code available 1
Device-device incompatibility 1
Dislodged or dislocated 1
Device disinfection or sterilization issue 1
Device markings issue 1
Other (for use when an appropriate device code cannot be identified) 1
Defective component 1
Tear, rip or hole in device packaging 1
Defective item 1
Delamination 1
Entrapment of device or device component 1
Inaccurate flowrate 1
Fracture 1
Hole in material 1
Occlusion within device 1
Unsealed device packaging 1
Peeled 1
Total Device Problems 142

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 0 2 3 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Aug-25-2010
2 Arrow International Inc II May-05-2010
3 Arrow International Inc II Jun-24-2009
4 Cook Inc. II Aug-22-2016
5 LifeCell Corporation II Oct-28-2010
6 Merit Medical Systems, Inc. II Dec-14-2009
7 Tri-State Hospital Supply Corporation I Mar-25-2009

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