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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stopcock, i.v. set
Regulation Description Intravascular administration set.
Product CodeFMG
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 4
HALKEY-ROBERTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 70
Disconnection 44
Leak 39
Component(s), broken 27
Crack 25
Connection issue 15
Detachment of device component 14
Break 13
Device damaged prior to use 11
Disassembly 9
Fracture 5
Kinked 5
Failure to prime 5
Dislodged or dislocated 5
Detachment of device or device component 4
Filling problem 4
Air leak 4
Infusion or flow issue 4
Improper or incorrect procedure or method 3
Blocked connection 3
No flow 3
Loose or intermittent connection 3
Failure to infuse 3
Reflux within device 2
Material separation 2
Device operates differently than expected 2
Device packaging compromised 2
Normal 2
Material deformation 2
Insufficient flow or underinfusion 1
Misconnection 1
Foreign material 1
Bent 1
Contamination during use 1
Inaccurate flowrate 1
Foreign material present in device 1
Incompatibility problem 1
Incorrect device or component shipped 1
Sticking 1
Use of Device Issue 1
Device, or device fragments remain in patient 1
Tube(s), buckling of 1
Split 1
Failure to disconnect 1
Total Device Problems 345

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 1 1 0 1 1 2 0 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jan-11-2012
2 Baxter Healthcare Corp. II Jun-22-2011
3 Baxter Healthcare Corp. II Dec-09-2010
4 ICU Medical, Inc. II Jan-10-2017
5 ICU Medical, Inc. II May-07-2015
6 ICU Medical, Inc. I Sep-19-2014
7 ICU Medical, Inc. II Aug-02-2012
8 ICU Medical, Inc. II Sep-16-2008
9 Merit Medical Systems, Inc. II May-31-2007
10 Value Plastics, Inc. II Mar-09-2016

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