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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiovascular procedure kit
Regulation Description Diagnostic intravascular catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEZ
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2020 65 65
2021 42 42
2022 36 36
2023 24 24
2024 147 147
2025 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 86 86
Break 30 30
Fluid/Blood Leak 26 26
Appropriate Term/Code Not Available 24 24
Leak/Splash 23 23
Material Fragmentation 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Crack 17 17
Loose or Intermittent Connection 15 15
Material Integrity Problem 15 15
Material Frayed 12 12
Material Separation 11 11
Unsealed Device Packaging 9 9
Insufficient Information 8 8
Disconnection 8 8
Device Contamination with Chemical or Other Material 7 7
Contamination 7 7
Contamination /Decontamination Problem 7 7
Air/Gas in Device 7 7
Component Missing 7 7
Tear, Rip or Hole in Device Packaging 6 6
Material Puncture/Hole 5 5
Pressure Problem 5 5
Component Misassembled 5 5
Detachment of Device or Device Component 5 5
Incomplete or Inadequate Connection 5 5
Infusion or Flow Problem 5 5
Device Handling Problem 4 4
Delivered as Unsterile Product 4 4
Device Contaminated During Manufacture or Shipping 3 3
Packaging Problem 3 3
Problem with Sterilization 3 3
Gas/Air Leak 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Mechanical Problem 3 3
Defective Device 3 3
Use of Device Problem 2 2
Improper Flow or Infusion 2 2
Degraded 2 2
Product Quality Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Human-Device Interface Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Loss of or Failure to Bond 2 2
Obstruction of Flow 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Material Twisted/Bent 1 1
Blocked Connection 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 283 283
Insufficient Information 50 50
No Known Impact Or Consequence To Patient 20 20
Air Embolism 19 19
Foreign Body In Patient 17 17
No Consequences Or Impact To Patient 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Blood Loss 4 4
Hemolysis 3 3
No Patient Involvement 3 3
Laceration(s) 3 3
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Exposure to Body Fluids 2 2
Hemorrhage/Bleeding 2 2
Arrhythmia 1 1
Death 1 1
Speech Disorder 1 1
Skin Inflammation/ Irritation 1 1
Perforation 1 1
Chemical Exposure 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Needle Stick/Puncture 1 1
Thrombosis/Thrombus 1 1
Visual Impairment 1 1
Therapeutic Response, Decreased 1 1
Low Blood Pressure/ Hypotension 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Aug-04-2025
2 AVID Medical, Inc. II May-09-2025
3 AVID Medical, Inc. II Nov-14-2024
4 American Contract Systems Inc II Aug-28-2025
5 American Contract Systems Inc II Mar-14-2025
6 American Contract Systems Inc. II Oct-16-2025
7 American Contract Systems, Inc. II Sep-24-2024
8 American Contract Systems, Inc. II Jan-26-2024
9 American Contract Systems, Inc. II Oct-26-2023
10 American Contract Systems, Inc. II Sep-08-2022
11 Avid Medical, Inc. I Jun-04-2021
12 Avid Medical, Inc. II Mar-19-2020
13 Cardinal Health 200, LLC II Feb-10-2025
14 Cardinal Health 200, LLC II Jan-15-2025
15 Cardinal Health 200, LLC II Jul-10-2024
16 Cardinal Health 200, LLC II Oct-10-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
18 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
19 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
20 MEDLINE INDUSTRIES, LP - Northfield II Mar-21-2025
21 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
22 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
31 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
32 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
33 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
34 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
35 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
36 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
37 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
38 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
39 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
41 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
42 Medline Industries Inc II Dec-10-2021
43 Medline Industries Inc II Jan-07-2021
44 Medline Industries, LP I Oct-01-2025
45 Merit Medical Systems, Inc. II Aug-12-2025
46 Merit Medical Systems, Inc. II Aug-12-2024
47 ROi CPS LLC II Nov-16-2023
48 ROi CPS LLC II Nov-23-2022
49 ROi CPS LLC II Jul-19-2022
50 ROi CPS LLC II Jun-28-2022
51 ROi CPS LLC II May-09-2022
52 ROi CPS LLC II Apr-08-2021
53 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
54 Terumo Cardiovascular Systems Corp II Apr-18-2022
55 Terumo Cardiovascular Systems Corporation II Mar-29-2024
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