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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ear, nose, and throat surgical tray
Regulation Description Ear, nose, and throat manual surgical instrument.
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 CodeOGR
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 3 3
2022 6 6
2023 3 3
2024 24 24
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Appropriate Term/Code Not Available 6 6
Material Fragmentation 4 4
Material Split, Cut or Torn 2 2
Fire 2 2
Device Markings/Labelling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Incomplete or Missing Packaging 1 1
Crack 1 1
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Foreign Body In Patient 6 6
Insufficient Information 4 4
Superficial (First Degree) Burn 2 2
Epistaxis 2 2
Burn(s) 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems, Inc. II Sep-24-2024
4 American Contract Systems, Inc. II Jan-26-2024
5 American Contract Systems, Inc. II Sep-08-2022
6 Cardinal Health 200, LLC II Feb-10-2025
7 Cardinal Health 200, LLC II Jan-15-2025
8 Cardinal Health 200, LLC II Oct-10-2023
9 Centurion Medical Products Corporation II Feb-05-2020
10 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
22 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
27 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
28 Medline Industries Inc II Jan-07-2021
29 ROi CPS LLC II Nov-23-2022
30 ROi CPS LLC II Jan-10-2022
31 ROi CPS LLC II Nov-18-2021
32 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
33 Windstone Medical Packaging, Inc. II Oct-08-2024
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