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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 5195
Leak 2099
Disconnection 1261
Material separation 970
Break 962
Failure to Adhere or Bond 774
Crack 719
Device operates differently than expected 588
Reflux within device 561
Detachment of device component 533
No flow 429
Failure to prime 409
Detachment of device or device component 407
Infusion or flow issue 269
Material deformation 262
Failure to deliver 250
Bent 237
Connection issue 229
Hole in material 206
Kinked 200
Occlusion within device 193
No Known Device Problem 192
Overdelivery 183
Sticking 171
Failure to infuse 169
Material rupture 164
Blockage within device or device component 149
Air leak 148
Insufficient flow or underinfusion 141
Improper flow or infusion 141
Valve(s), failure of 132
Excess flow or overinfusion 130
Material fragmentation 116
Free or unrestricted flow 113
Accuracy rate 105
Device alarm system issue 101
Cut in material 100
Foreign material present in device 99
Material integrity issue 92
Difficult or delayed activation 92
Buckled material 87
Component(s), broken 84
Dislodged or dislocated 79
Component missing 78
Unknown (for use when the device problem is not known) 73
Loss of or failure to bond 72
Loose or intermittent connection 72
Filling problem 71
No Information 70
Device displays error message 68
Fitting problem 64
Material puncture 56
Particulates 55
Device, or device fragments remain in patient 54
Mechanical issue 49
Failure to disconnect 48
Protective measure issue 46
Fracture 45
Tube(s), defective 42
Failure to separate 41
Manufacturing or shipping issue associated with device 38
Packaging issue 37
Improper or incorrect procedure or method 35
Failure to reset 35
Product quality issue 34
Defective item 34
Other (for use when an appropriate device code cannot be identified) 33
Migration of device or device component 31
Stretched 30
Deployment issue 30
Failure to advance 29
Failure to deploy 28
Slippage of device or device component 27
Use of Device Issue 27
Defective component 27
Not Applicable 26
Melted 24
Inaccurate flowrate 24
Torn material 23
Split 23
Material Distortion 23
No code available 22
Fail-safe design failure 20
Bleed back 19
Volume accuracy issue 19
Inaccurate delivery 18
Difficult to remove 18
Burst 18
Device or device fragments location unknown 18
Obstruction within device 16
Fail-safe mechanism issue 16
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 clogged 12
Device contamination with blood or blood product 12
Device damaged prior to use 12
Total Device Problems 21461

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

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