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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, blood circuit, hemodialysis
Regulation Description Hemodialysis system and accessories.
Product CodeKOC
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
ASAHI
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 4
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 5
GAMBRO
  SUBSTANTIALLY EQUIVALENT 9
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 2
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 5
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NISSHO CORP
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 5
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fluid leak 645
Disconnection 44
Material separation 27
No Known Device Problem 13
Air leak 10
Crack 9
Leak 8
Loose or intermittent connection 3
Hole in material 3
No Information 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Cut in material 2
Connection issue 1
Device-device incompatibility 1
Improper flow or infusion 1
Misconnection 1
Kinked 1
Material discolored 1
Device alarm system issue 1
Burn of device or device component 1
Coagulation in device or device ingredient 1
Detachment of device component 1
Total Device Problems 780

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

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Jun-05-2015
2 Fresenius Medical Care Holdings, Inc. II Feb-03-2015
3 Fresenius Medical Care North America II Jan-23-2009
4 Molded Products Inc II Mar-18-2013

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