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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, enteral
Regulation Description Infusion pump.
Product CodeLZH
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  1
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  1
  SUBSTANTIALLY EQUIVALENT 1
ROSS PRODUCT DIV. ABBOTT LABORATORIES
  1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ZEVEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 1661
Underdelivery 136
Failure to prime 134
Insufficient flow or underinfusion 80
Failure to auto stop 40
Overdelivery 38
Excess flow or overinfusion 37
Other (for use when an appropriate device code cannot be identified) 36
Loss of power 35
Protective measure issue 33
Infusion or flow issue 32
Device alarm system issue 27
Defective Alarm 23
Melted 18
Break 16
Electrical issue 15
Failure to deliver 14
Inaccurate delivery 14
Power source issue 13
Arcing 9
No Information 8
Component missing 8
Low battery 7
Smoking 6
False alarm 6
Fire 6
Battery issue 5
Fail-safe mechanism issue 5
Cut in material 5
Pumping stopped 4
Free or unrestricted flow 4
Burn of device or device component 4
Failure to infuse 4
No display or display failure 4
Not audible alarm 4
Alarm, audible 4
Implant Mobility NOS (Not otherwise specified) 3
Inadequate lighting 3
Device displays error message 3
No Known Device Problem 3
Loose or intermittent connection 3
Volume accuracy issue 2
Overheating of device or device component 2
Blockage within device or device component 2
Shock, electrical 2
Alarm not visible 2
Leak 2
Use of Device Issue 2
Device operates differently than expected 2
Motor drive unit (MDU) stalled or jammed 2
Spark 2
Device inoperable 2
Failure to fire 2
Adaptor, failure of 2
Issue with displayed error message 1
Charging issue 1
Blank screen 1
Tube(s), defective 1
Fuse, blown 1
Improper or incorrect procedure or method 1
Programming issue 1
Prompts will not clear 1
Motor failure 1
Compatibility 1
No code available 1
Failure to charge 1
Failure to pump 1
Balloon rupture 1
Not Applicable 1
Alarm, failure of low flow 1
Electrical power problem 1
Device remains activated 1
Occlusion within device 1
Inappropriate or unexpected reset 1
Battery failure 1
Reset issue 1
Image display error 1
Material deformation 1
Fail-safe design failure 1
Use of Incorrect Control Settings 1
Applicator failure 1
Pumping issue 1
Expulsion 1
Failure to power-up 1
Charred 1
Fluid leak 1
Mechanical issue 1
Crack 1
Incorrect display 1
Naturally worn 1
Blocked connection 1
Disconnection 1
Total Device Problems 2574

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Sep-20-2008
2 Abbott Nutrition, Abbott Laboratories II Sep-21-2009
3 CORPAK MedSystems II Oct-25-2011
4 MOOG Medical Devices Group II Jan-31-2013
5 MOOG Medical Devices Group II Nov-15-2012
6 Medtronic II May-10-2016
7 Ross Products Division Abbott Laboratories II Aug-08-2007
8 Ross Products Division Abbott Laboratories II Aug-07-2007
9 Zevex International, Inc. II Sep-21-2009

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