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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device central venous catheter tray
Regulation Description Venous blood pressure manometer.
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 CodeOFF
Regulation Number 870.1140
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 2 2
2023 7 7
2024 28 28
2025 16 16
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 10 10
Break 9 9
Material Integrity Problem 6 6
Material Twisted/Bent 4 4
Appropriate Device Problem Term/Code Not Available 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Leak/Splash 2 2
Contamination 2 2
Material Separation 2 2
Fluid/Blood Leak 2 2
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Material Disintegration 1 1
Difficult to Flush 1 1
Material Puncture/Hole 1 1
Difficult to Advance 1 1
Defective Component 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Adhesive Too Strong 1 1
Failure to Align 1 1
Insufficient Device Problem Information 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Component Incompatible 1 1
Corroded 1 1
Dull, Blunt 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
Insufficient Information 4 4
Bacterial Infection 2 2
Failure of Implant 1 1
Skin Inflammation/ Irritation 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Viral Infection 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Laceration(s) 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc. II Oct-16-2025
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
11 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Oct-13-2022
19 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
20 Medical Action Industries, Inc. 306 II Nov-18-2022
21 Medical Action Industries, Inc. 306 I May-12-2021
22 Medline Industries Inc II Dec-10-2021
23 Medline Industries, LP II Aug-31-2026
24 Medline Industries, LP II Jun-26-2026
25 Medline Industries, LP II Jun-25-2026
26 Medline Industries, LP I Jun-24-2026
27 Medline Industries, LP II Jun-17-2026
28 Medline Industries, LP II Jun-12-2026
29 Medline Industries, LP II May-07-2026
30 Medline Industries, LP II Apr-30-2026
31 Medline Industries, LP II Apr-17-2026
32 Medline Industries, LP II Apr-17-2026
33 Medline Industries, LP I Apr-07-2026
34 Medline Industries, LP II Apr-01-2026
35 Medline Industries, LP II Feb-17-2026
36 Medline Industries, LP II Feb-09-2026
37 Medline Industries, LP II Jan-12-2026
38 Medline Industries, LP II Nov-14-2025
39 Stradis Healthcare II Jan-11-2023
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