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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 242
Fluid leak 157
Device operates differently than expected 43
Hole in material 21
Break 13
Disconnection 12
Leak 11
Material rupture 11
Material separation 6
Delivered as unsterile product 6
Connection issue 4
Chemical spillage 3
Fitting problem 3
Device Difficult to Setup or Prepare 2
Detachment of device component 2
Defective item 2
Free or unrestricted flow 1
Material deformation 1
No flow 1
No Known Device Problem 1
Scratched material 1
No Information 1
Kinked 1
Incorrect measurement 1
Defective component 1
Underdelivery 1
Tear, rip or hole in device packaging 1
Slippage of device or device component 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Total Device Problems 553

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 1 0
Class II 1 1 1 1 4 1 4 2 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 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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