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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, i.v. fluid transfer
Regulation Description Intravascular administration set.
Product CodeLHI
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 11
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 12
BD
  SUBSTANTIALLY EQUIVALENT 1
BERLEX
  SUBSTANTIALLY EQUIVALENT 1
BIOJECT, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARDIOMED
  SUBSTANTIALLY EQUIVALENT 1
CARMEL PHARMA, INC
  SUBSTANTIALLY EQUIVALENT 7
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 1
HALKEY-ROBERTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INRAD
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
METRIX CO.
  SUBSTANTIALLY EQUIVALENT 1
MIGADA PLANT
  SUBSTANTIALLY EQUIVALENT 2
NEXUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Q.I. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Foreign material present in device 60
Device operates differently than expected 30
Fluid leak 17
Break 8
Leak 7
Fitting problem 3
Chemical spillage 3
Connection issue 3
Device Difficult to Setup or Prepare 2
Detachment of device component 2
Disconnection 1
Kinked 1
Slippage of device or device component 1
Insufficient flow or underinfusion 1
Incorrect measurement 1
Underdelivery 1
Free or unrestricted flow 1
No Known Device Problem 1
No Information 1
Total Device Problems 144

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 1 1 1 1 4 1 4 2 0 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical Inc I Nov-05-2010
2 B. Braun Medical, Inc. II Nov-27-2013
3 B. Braun Medical, Inc. II May-05-2007
4 Baxa Corporation II Sep-06-2013
5 Baxa Corporation II Jul-18-2013
6 Baxa Corporation II Apr-13-2012
7 Baxa Corporation II Apr-12-2011
8 Baxa Corporation II Mar-23-2010
9 Baxter Healthcare Corp. II Jul-01-2014
10 Baxter Healthcare Corp. II Nov-26-2013
11 Baxter Healthcare Corp. II Sep-23-2011
12 Baxter Healthcare Corp. II May-25-2011
13 Baxter Healthcare Corp. II Feb-22-2011
14 Baxter Healthcare Corp. II Aug-24-2008
15 Excelsior Medical Corp II Jul-16-2014
16 Migada Inc. II May-06-2009
17 Smiths Medical Asd Inc III Jul-30-2008

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