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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
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
2019 2 2
2020 1 1
2021 4 4
2022 2 2
2023 7 7
2024 22 22

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Viral Infection 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 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 Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Oct-13-2022
14 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
15 Medical Action Industries, Inc. 306 II Nov-18-2022
16 Medical Action Industries, Inc. 306 I May-12-2021
17 Medline Industries Inc II Dec-10-2021
18 Resource Optimization & Innovation LLC II Jun-15-2020
19 Stradis Healthcare II Jan-11-2023
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