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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 8
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 4715
Leak 1912
Disconnection 1130
Material separation 898
Break 861
Failure to Adhere or Bond 726
Crack 669
Device operates differently than expected 541
Reflux within device 530
Detachment of device component 505
No flow 387
Failure to prime 370
Detachment of device or device component 342
Infusion or flow issue 255
Failure to deliver 250
Material deformation 240
Connection issue 220
Bent 194
Kinked 192
Hole in material 185
Overdelivery 183
Occlusion within device 173
Sticking 169
Failure to infuse 161
Material rupture 160
No Known Device Problem 159
Air leak 147
Improper flow or infusion 141
Insufficient flow or underinfusion 140
Valve(s), failure of 132
Excess flow or overinfusion 126
Blockage within device or device component 109
Free or unrestricted flow 108
Accuracy rate 105
Cut in material 92
Difficult or delayed activation 92
Material fragmentation 91
Foreign material present in device 90
Material integrity issue 88
Buckled material 86
Component(s), broken 84
Component missing 74
Unknown (for use when the device problem is not known) 73
No Information 69
Dislodged or dislocated 67
Device alarm system issue 65
Device displays error message 64
Loss of or failure to bond 61
Fitting problem 57
Filling problem 56
Particulates 55
Material puncture 54
Device, or device fragments remain in patient 54
Mechanical issue 49
Loose or intermittent connection 47
Fracture 44
Tube(s), defective 42
Failure to separate 41
Failure to disconnect 38
Manufacturing or shipping issue associated with device 38
Packaging issue 36
Improper or incorrect procedure or method 35
Failure to reset 35
Other (for use when an appropriate device code cannot be identified) 33
Protective measure issue 31
Defective item 30
Stretched 30
Product quality issue 30
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
Melted 24
Inaccurate flowrate 24
Not Applicable 24
Material Distortion 23
Torn material 22
Defective component 22
Split 21
Deployment issue 20
No code available 19
Volume accuracy issue 19
Fail-safe design failure 19
Bleed back 19
Inaccurate delivery 18
Difficult to remove 17
Burst 17
Device or device fragments location unknown 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
Device contamination with blood or blood product 12
Underdelivery 11
Device damaged prior to use 11
Total Device Problems 19669

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 5
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 Feb-28-2017
39 CareFusion 303, Inc. II Feb-28-2017
40 CareFusion 303, Inc. II Mar-17-2016
41 CareFusion 303, Inc. II Dec-17-2015
42 CareFusion 303, Inc. II Nov-05-2015
43 CareFusion 303, Inc. II Feb-04-2015
44 CareFusion 303, Inc. II Jul-09-2014
45 CareFusion 303, Inc. II Apr-16-2014
46 CareFusion 303, Inc. II Feb-04-2014
47 CareFusion 303, Inc. II Feb-03-2014
48 CareFusion 303, Inc. II Dec-04-2013
49 CareFusion 303, Inc. II Dec-03-2013
50 CareFusion 303, Inc. II Sep-26-2013
51 CareFusion 303, Inc. II Sep-26-2013
52 CareFusion 303, Inc. II Sep-26-2013
53 Carefusion 303 Inc II Feb-15-2013
54 Carefusion 303, Inc. II Jun-29-2011
55 Carmel Pharma, Inc. II Aug-22-2007
56 Centurion Medical Products Corporation II Feb-23-2016
57 Churchill Medical Systems, Inc. II Apr-21-2015
58 Churchill Medical Systems, Inc. II Jan-23-2014
59 Churchill Medical Systems, Inc. II Sep-18-2013
60 Churchill Medical Systems, Inc. II Mar-06-2013
61 Churchill Medical Systems, Inc. II Feb-16-2011
62 Churchill Medical Systems, Inc. II May-21-2010
63 Codan Us Corporation II Jul-10-2014
64 ConMed Corporation II Jan-11-2012
65 ConMed Corporation II Jan-11-2012
66 Curlin Medical Llc II Aug-07-2007
67 Exelint International Co. I Jan-22-2010
68 Global Healthcare Inc II Feb-03-2016
69 Hospira Inc. II Jun-29-2016
70 Hospira Inc. II Mar-06-2014
71 Hospira Inc. II Jul-18-2013
72 Hospira Inc. II Jul-25-2012
73 Hospira Inc. II Jan-19-2012
74 Hospira Inc. II Nov-25-2011
75 Hospira Inc. II Sep-29-2010
76 Hospira Inc. II Apr-15-2010
77 Hospira Inc. II Mar-09-2010
78 Hospira Inc. II Feb-22-2010
79 Hospira Inc. II Feb-27-2007
80 ICU Medical, Inc. II Jan-10-2017
81 ICU Medical, Inc. II Jan-09-2014
82 ICU Medical, Inc. II Jan-11-2012
83 ICU Medical, Inc. II Aug-16-2007
84 Medical Action Industries Inc I Mar-30-2010
85 Medical Product Specialist Inc dba MPS Acacia I Mar-30-2010
86 Medical Specialties Distributors, Inc. II Aug-09-2012
87 Medrad Inc II Dec-20-2012
88 Medtronic MiniMed I Jul-09-2013
89 Medtronic MiniMed I Jul-16-2009
90 Medtronic MiniMed Inc. II Dec-12-2014
91 Medtronic Minimed II Nov-17-2011
92 Merit Medical Systems, Inc. II Nov-21-2016
93 Merit Medical Systems, Inc. II Sep-11-2008
94 Navilyst Medical, Inc. II Jan-24-2014
95 RGI Medical Manufacturing, Inc. II Jul-07-2014
96 Roche Diagnostics Operations, Inc. II Dec-30-2014
97 Rymed Technologies, LLC II Jan-21-2016
98 Smiths Medical ASD, Inc. II May-27-2016
99 Smiths Medical ASD, Inc. II Mar-17-2015
100 Smiths Medical ASD, Inc. II Jan-17-2012
101 Smiths Medical Asd Inc II Jun-08-2015
102 Smiths Medical MD, Inc. II Apr-20-2009
103 Smiths Medical MD, Inc. II Feb-13-2008
104 Smiths Medical MD, Inc. II Aug-30-2007
105 US Infusion Inc dba Trucare Biomedix-USA II Mar-13-2015
106 Unomedical As II Nov-03-2016
107 Unomedical As II Jun-19-2015
108 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
109 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Dec-18-2016
110 WalkMed Infusion, LLC II Jul-18-2016
111 Zyno Medical LLC II Sep-27-2016

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