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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 24
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 60
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
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
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 9
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 5890
Leak 2353
Disconnection 1402
Break 1052
Material separation 1025
Failure to Adhere or Bond 919
Crack 806
Device operates differently than expected 661
Reflux within device 620
Detachment of device component 574
No flow 507
Failure to prime 465
Detachment of device or device component 462
Bent 360
Infusion or flow issue 308
Material deformation 307
Kinked 268
No Known Device Problem 260
Hole in material 254
Failure to deliver 250
Connection issue 247
Occlusion within device 243
Overdelivery 183
Failure to infuse 181
Sticking 180
Blockage within device or device component 171
Material rupture 169
Insufficient flow or underinfusion 149
Air leak 149
Improper flow or infusion 148
Excess flow or overinfusion 133
Material fragmentation 132
Valve(s), failure of 132
Free or unrestricted flow 118
Foreign material present in device 116
Device alarm system issue 116
Accuracy rate 105
Cut in material 105
Difficult or delayed activation 94
Material integrity issue 94
Dislodged or dislocated 90
Buckled material 89
Filling problem 87
Component(s), broken 84
Component missing 83
Device displays error message 80
Loose or intermittent connection 79
No Information 76
Loss of or failure to bond 75
Improper or incorrect procedure or method 74
Unknown (for use when the device problem is not known) 73
Protective measure issue 72
Fitting problem 66
Material puncture 57
Particulates 55
Device, or device fragments remain in patient 54
Mechanical issue 52
Failure to disconnect 50
Fracture 47
Defective item 45
Failure to separate 44
Tube(s), defective 42
Manufacturing or shipping issue associated with device 38
Packaging issue 38
Failure to reset 35
Product quality issue 35
Other (for use when an appropriate device code cannot be identified) 33
Stretched 32
Migration of device or device component 31
Deployment issue 30
Failure to advance 29
Failure to deploy 29
Use of Device Issue 28
No code available 28
Not Applicable 28
Defective component 27
Slippage of device or device component 27
Melted 24
Inaccurate flowrate 24
Torn material 24
Material Distortion 24
Split 23
Fail-safe design failure 22
Burst 20
Bleed back 19
Volume accuracy issue 19
Difficult to remove 18
Inaccurate delivery 18
Device or device fragments location unknown 18
Obstruction within device 17
Fail-safe mechanism issue 16
Retraction problem 15
Device damaged prior to use 15
Tears, rips, holes in device, device material 14
Material disintegration 14
Tear, rip or hole in device packaging 14
Tube(s), buckling of 13
Delivery system failure 13
Device clogged 13
Shelf life exceeded 13
Total Device Problems 24060

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 13
Class III 0 0 0 0 0 0 0 0 0 0 0

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

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