• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device set, administration, intravascular
Regulation Description Intravascular administration set.
Product CodeFPA
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 31
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIMAS
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
AVAIL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 22
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 58
BD
  SUBSTANTIALLY EQUIVALENT 7
BIOMEDIX
  SUBSTANTIALLY EQUIVALENT 3
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CARDIOMED
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DRAGON HEART MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 6
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 14
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 9
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 25
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 12
INNOVATIVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
JMS
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
LABORATOIRES PEROUSE
  SUBSTANTIALLY EQUIVALENT 1
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
LEVENTON, S.A.
  SUBSTANTIALLY EQUIVALENT 1
Lifemed of California
  SUBSTANTIALLY EQUIVALENT 2
MAERSK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARCAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 11
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 2
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 5
MEDEX
  SUBSTANTIALLY EQUIVALENT 9
MEDIKMARK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 14
MEINNTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MIGADA PLANT
  SUBSTANTIALLY EQUIVALENT 1
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NEXUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 13
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 6
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
RYMED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 15
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 13
TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 8
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 4
VENETEC
  SUBSTANTIALLY EQUIVALENT 2
VENUSA LTD.
  SUBSTANTIALLY EQUIVALENT 5
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 8
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 4518
Leak 1776
Disconnection 1078
Material separation 880
Break 843
Failure to Adhere or Bond 708
Crack 643
Reflux within device 518
Device operates differently than expected 518
Detachment of device component 500
No flow 368
Failure to prime 355
Detachment of device or device component 337
Infusion or flow issue 251
Failure to deliver 250
Material deformation 234
Connection issue 215
Overdelivery 183
Hole in material 181
Kinked 173
Bent 173
Sticking 168
Occlusion within device 168
Material rupture 159
Failure to infuse 159
No Known Device Problem 154
Air leak 146
Improper flow or infusion 139
Valve(s), failure of 132
Excess flow or overinfusion 122
Free or unrestricted flow 110
Accuracy rate 105
Blockage within device or device component 104
Material fragmentation 93
Cut in material 93
Difficult or delayed activation 92
Buckled material 84
Foreign material present in device 84
Component(s), broken 84
Insufficient flow or underinfusion 84
Material integrity issue 81
Component missing 74
Unknown (for use when the device problem is not known) 73
Dislodged or dislocated 66
No Information 66
Device displays error message 61
Loss of or failure to bond 61
Device alarm system issue 57
Fitting problem 57
Particulates 55
Device, or device fragments remain in patient 54
Material puncture 53
Filling problem 50
Mechanical issue 49
Fracture 43
Loose or intermittent connection 42
Tube(s), defective 42
Failure to separate 41
Manufacturing or shipping issue associated with device 38
Failure to disconnect 36
Failure to reset 35
Packaging issue 34
Other (for use when an appropriate device code cannot be identified) 33
Improper or incorrect procedure or method 33
Stretched 31
Product quality issue 30
Protective measure issue 29
Defective item 29
Failure to advance 29
Failure to deploy 28
Slippage of device or device component 27
Use of Device Issue 26
Migration of device or device component 25
Material Distortion 25
Melted 24
Inaccurate flowrate 24
Torn material 21
Not Applicable 21
Deployment issue 20
Defective component 20
Volume accuracy issue 19
Fail-safe design failure 19
Bleed back 19
Split 19
No code available 19
Device or device fragments location unknown 17
Burst 17
Inaccurate delivery 17
Difficult to remove 17
Fail-safe mechanism issue 16
Obstruction within device 15
Tears, rips, holes in device, device material 14
Retraction problem 13
Material disintegration 13
Tube(s), buckling of 13
Delivery system failure 13
Improper chemical reaction 12
Connection error 11
Shelf life exceeded 11
Device contamination with blood or blood product 11
Total Device Problems 18930

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 5 0 1 1 0 0 0 0
Class II 9 4 5 10 7 9 13 16 12 13 2
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arizant Healthcare, Inc II Aug-18-2007
2 Arrow International Inc I Mar-30-2010
3 Arrow International Inc II Jun-24-2009
4 Asante Solutions, Inc. II Dec-27-2013
5 B. Braun Medical, Inc. II Jul-09-2014
6 B. Braun Medical, Inc. II Feb-18-2014
7 B. Braun Medical, Inc. II Jan-26-2010
8 B. Braun Medical, Inc. II Jun-05-2009
9 B. Braun Medical, Inc. II Oct-24-2008
10 B. Braun Medical, Inc. II Sep-23-2008
11 B. Braun Medical, Inc. II May-31-2007
12 Bard Access Systems II Jan-10-2017
13 Bard Access Systems II Apr-30-2015
14 Bard Access Systems II Mar-13-2015
15 Bard Access Systems II Feb-26-2010
16 Baxter Healthcare Corp II Oct-16-2015
17 Baxter Healthcare Corp II Sep-09-2014
18 Baxter Healthcare Corp. II Aug-29-2016
19 Baxter Healthcare Corp. II Jan-07-2016
20 Baxter Healthcare Corp. II Oct-30-2013
21 Baxter Healthcare Corp. II Oct-29-2013
22 Baxter Healthcare Corp. II May-07-2013
23 Baxter Healthcare Corp. I Oct-09-2012
24 Baxter Healthcare Corp. II Jan-11-2012
25 Baxter Healthcare Corp. II Aug-03-2011
26 Baxter Healthcare Corp. II Jul-15-2011
27 Baxter Healthcare Corp. II Jun-29-2011
28 Baxter Healthcare Corp. II Dec-01-2010
29 Baxter Healthcare Corp. II Oct-27-2010
30 Baxter Healthcare Corp. II Oct-15-2010
31 Baxter Healthcare Corp. II Dec-09-2009
32 Baxter Healthcare Corp. II Mar-14-2007
33 Becton Dickinson & Company II Mar-25-2015
34 Becton Dickinson Medical Systems I Feb-02-2010
35 Biomedix, Inc. II Oct-06-2014
36 C.R. Bard, Inc., Urological Division II Jun-29-2009
37 Cardinal Health 303 Inc DBA Alaris Products II Nov-08-2007
38 CareFusion 303, Inc. II Mar-17-2016
39 CareFusion 303, Inc. II Dec-17-2015
40 CareFusion 303, Inc. II Nov-05-2015
41 CareFusion 303, Inc. II Feb-04-2015
42 CareFusion 303, Inc. II Jul-09-2014
43 CareFusion 303, Inc. II Apr-16-2014
44 CareFusion 303, Inc. II Feb-04-2014
45 CareFusion 303, Inc. II Feb-03-2014
46 CareFusion 303, Inc. II Dec-04-2013
47 CareFusion 303, Inc. II Dec-03-2013
48 CareFusion 303, Inc. II Sep-26-2013
49 CareFusion 303, Inc. II Sep-26-2013
50 CareFusion 303, Inc. II Sep-26-2013
51 Carefusion 303 Inc II Feb-15-2013
52 Carefusion 303, Inc. II Jun-29-2011
53 Carmel Pharma, Inc. II Aug-22-2007
54 Centurion Medical Products Corporation II Feb-23-2016
55 Churchill Medical Systems, Inc. II Apr-21-2015
56 Churchill Medical Systems, Inc. II Jan-23-2014
57 Churchill Medical Systems, Inc. II Sep-18-2013
58 Churchill Medical Systems, Inc. II Mar-06-2013
59 Churchill Medical Systems, Inc. II Feb-16-2011
60 Churchill Medical Systems, Inc. II May-21-2010
61 Codan Us Corporation II Jul-10-2014
62 ConMed Corporation II Jan-11-2012
63 ConMed Corporation II Jan-11-2012
64 Curlin Medical Llc II Aug-07-2007
65 Exelint International Co. I Jan-22-2010
66 Global Healthcare Inc II Feb-03-2016
67 Hospira Inc. II Jun-29-2016
68 Hospira Inc. II Mar-06-2014
69 Hospira Inc. II Jul-18-2013
70 Hospira Inc. II Jul-25-2012
71 Hospira Inc. II Jan-19-2012
72 Hospira Inc. II Nov-25-2011
73 Hospira Inc. II Sep-29-2010
74 Hospira Inc. II Apr-15-2010
75 Hospira Inc. II Mar-09-2010
76 Hospira Inc. II Feb-22-2010
77 Hospira Inc. II Feb-27-2007
78 ICU Medical, Inc. II Jan-10-2017
79 ICU Medical, Inc. II Jan-09-2014
80 ICU Medical, Inc. II Jan-11-2012
81 ICU Medical, Inc. II Aug-16-2007
82 Medical Action Industries Inc I Mar-30-2010
83 Medical Product Specialist Inc dba MPS Acacia I Mar-30-2010
84 Medical Specialties Distributors, Inc. II Aug-09-2012
85 Medrad Inc II Dec-20-2012
86 Medtronic MiniMed I Jul-09-2013
87 Medtronic MiniMed I Jul-16-2009
88 Medtronic MiniMed Inc. II Dec-12-2014
89 Medtronic Minimed II Nov-17-2011
90 Merit Medical Systems, Inc. II Nov-21-2016
91 Merit Medical Systems, Inc. II Sep-11-2008
92 Navilyst Medical, Inc. II Jan-24-2014
93 RGI Medical Manufacturing, Inc. II Jul-07-2014
94 Roche Diagnostics Operations, Inc. II Dec-30-2014
95 Rymed Technologies, LLC II Jan-21-2016
96 Smiths Medical ASD, Inc. II May-27-2016
97 Smiths Medical ASD, Inc. II Mar-17-2015
98 Smiths Medical ASD, Inc. II Jan-17-2012
99 Smiths Medical Asd Inc II Jun-08-2015
100 Smiths Medical MD, Inc. II Apr-20-2009
101 Smiths Medical MD, Inc. II Feb-13-2008
102 Smiths Medical MD, Inc. II Aug-30-2007
103 US Infusion Inc dba Trucare Biomedix-USA II Mar-13-2015
104 Unomedical As II Nov-03-2016
105 Unomedical As II Jun-19-2015
106 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Dec-18-2016
107 WalkMed Infusion, LLC II Jul-18-2016
108 Zyno Medical LLC II Sep-27-2016

-
-