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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

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 10 10
Break 7 7
Material Integrity Problem 4 4
Appropriate 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 Twisted/Bent 2 2
Difficult to Open or Remove Packaging Material 1 1
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Insufficient Information 1 1
Defective Component 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Component Missing 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Skin Inflammation/ Irritation 1 1
Needle Stick/Puncture 1 1
Viral Infection 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 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 Jan-12-2026
24 Medline Industries, LP II Nov-14-2025
25 Stradis Healthcare II Jan-11-2023
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