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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
2020 1 1
2021 4 4
2022 2 2
2023 7 7
2024 28 28
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 10 10
Appropriate Term/Code Not Available 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Break 3 3
Material Twisted/Bent 2 2
Leak/Splash 2 2
Material Integrity Problem 2 2
Contamination 2 2
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Advance 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Temperature Problem 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
Insufficient Information 4 4
Bacterial Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Viral Infection 1 1
Failure of Implant 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Sep-08-2022
3 Centurion Medical Products Corporation II Feb-05-2020
4 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Oct-13-2022
17 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
18 Medical Action Industries, Inc. 306 II Nov-18-2022
19 Medical Action Industries, Inc. 306 I May-12-2021
20 Medline Industries Inc II Dec-10-2021
21 Resource Optimization & Innovation LLC II Jun-15-2020
22 Stradis Healthcare II Jan-11-2023
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