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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, tubing, blood, with and without anti-regurgitation valve
Regulation Description Hemodialysis system and accessories.
Product CodeFJK
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 4
GAMBRO
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 139
No Known Device Problem 126
Material separation 101
Kinked 96
Leak 56
No Information 51
Disconnection 39
Unknown (for use when the device problem is not known) 32
Detachment of device component 17
Air leak 15
Hole in material 15
Normal 12
Connection issue 12
Not Applicable 11
Other (for use when an appropriate device code cannot be identified) 10
Crack 10
Loose or intermittent connection 9
Defective component 9
No code available 9
Device operates differently than expected 8
Cut in material 8
Use of Device Issue 7
Dislodged or dislocated 7
Misconnection 7
Occlusion within device 6
Method, improper/incorrect 6
Overdelivery 6
Loss of or failure to bond 5
Break 4
Coagulation in device or device ingredient 4
Device alarm system issue 4
Material rupture 4
Tip breakage 3
Split 3
Failure to Adhere or Bond 3
Source, detachment from 3
Decrease in pressure 2
Increase in pressure 2
Migration of device or device component 2
Device maintenance issue 2
Mechanical issue 2
Defective Alarm 2
Burst 2
Decoupling 2
Device damaged prior to use 2
Filtration issue 2
Foreign material present in device 1
Improper flow or infusion 1
Infusion or flow issue 1
Difficult to open or close 1
Tube(s), shattering of 1
Unit inactivated 1
Improper or incorrect procedure or method 1
Suction issue 1
Patient-device incompatibility 1
Detachment of device or device component 1
Device Issue 1
Tube(s), defective 1
Inadequate filtration process 1
Connector pin failure 1
Couple, failure to 1
Dislocated 1
Emergency stop button or switch failure 1
Filter 1
Restricted flowrate 1
Component(s), broken 1
Blockage within device or device component 1
Fracture 1
Reaction 1
Alarm system, failure of check-catheter 1
Total Device Problems 901

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

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. III May-07-2008
2 Fresenius Medical Care Holdings, Inc. I Jan-10-2011
3 Gambro Renal Products, Inc. II Sep-26-2008
4 Gambro Renal Products, Incorporated II Apr-11-2014
5 Nipro Medical Corporation II Jan-08-2016

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