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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 78
Disconnection 47
Leak 41
Component(s), broken 27
Crack 25
Break 16
Connection issue 15
Detachment of device component 14
Device damaged prior to use 11
Disassembly 9
Kinked 6
No flow 6
Dislodged or dislocated 5
Infusion or flow issue 5
Fracture 5
Failure to prime 5
Detachment of device or device component 4
Air leak 4
Loose or intermittent connection 4
Filling problem 4
Mechanical issue 3
Device operates differently than expected 3
Failure to infuse 3
Improper or incorrect procedure or method 3
Blocked connection 3
Material deformation 2
Normal 2
Failure to disconnect 2
Foreign material present in device 2
Material separation 2
Reflux within device 2
Device packaging compromised 2
Tube(s), buckling of 1
Split 1
Device, or device fragments remain in patient 1
Sticking 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
Misconnection 1
Inaccurate flowrate 1
Foreign material 1
Bent 1
Device clogged 1
Contamination during use 1
Incompatibility problem 1
Incorrect device or component shipped 1
Total Device Problems 374

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 2
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 Elcam Medical, Inc. II Apr-20-2017
5 ICU Medical, Inc. II Jan-10-2017
6 ICU Medical, Inc. II May-07-2015
7 ICU Medical, Inc. I Sep-19-2014
8 ICU Medical, Inc. II Aug-02-2012
9 ICU Medical, Inc. II Sep-16-2008
10 Merit Medical Systems, Inc. II May-31-2007
11 Value Plastics, Inc. II Mar-09-2016

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