• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 50
Leak 9
Air leak 9
Unraveled material 6
Failure to Adhere or Bond 5
Difficult to remove 5
Material separation 5
Detachment of device component 4
Break 4
Disconnection 3
Crack 2
Detachment of device or device component 2
Stretched 2
Device operates differently than expected 2
Human-Device Interface Issue 2
Loss of or failure to bond 2
Delamination 1
Dislodged or dislocated 1
No code available 1
No Known Device Problem 1
Material frayed 1
Occlusion within device 1
Defective component 1
Other (for use when an appropriate device code cannot be identified) 1
Defective item 1
Entrapment of device or device component 1
Device disinfection or sterilization issue 1
Device markings issue 1
Peeled 1
Device-device incompatibility 1
Hole in material 1
Unsealed device packaging 1
Total Device Problems 128

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 0
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 LifeCell Corporation II Oct-28-2010
5 Merit Medical Systems, Inc. II Dec-14-2009
6 Tri-State Hospital Supply Corporation I Mar-25-2009

-
-