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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 90
Device operates differently than expected 38
Fluid leak 23
Break 8
Leak 7
Connection issue 4
Chemical spillage 3
Fitting problem 3
Defective item 2
Detachment of device component 2
Device Difficult to Setup or Prepare 2
Material separation 1
Slippage of device or device component 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
Disconnection 1
Kinked 1
Underdelivery 1
Incorrect measurement 1
Free or unrestricted flow 1
No Known Device Problem 1
No Information 1
Total Device Problems 193

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 1
Class II 1 1 1 1 4 1 4 2 0 1
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 Jun-02-2016
3 B. Braun Medical, Inc. II Nov-27-2013
4 B. Braun Medical, Inc. II May-05-2007
5 Baxa Corporation II Sep-06-2013
6 Baxa Corporation II Jul-18-2013
7 Baxa Corporation II Apr-13-2012
8 Baxa Corporation II Apr-12-2011
9 Baxa Corporation II Mar-23-2010
10 Baxter Corporation Englewood I Oct-06-2016
11 Baxter Healthcare Corp. II Jul-01-2014
12 Baxter Healthcare Corp. II Nov-26-2013
13 Baxter Healthcare Corp. II Sep-23-2011
14 Baxter Healthcare Corp. II May-25-2011
15 Baxter Healthcare Corp. II Feb-22-2011
16 Baxter Healthcare Corp. II Aug-24-2008
17 Excelsior Medical Corp II Jul-16-2014
18 Migada Inc. II May-06-2009
19 Smiths Medical Asd Inc III Jul-30-2008

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