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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
2021 3 3
2022 6 6
2023 3 3
2024 24 24
2025 9 9
2026 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Material Integrity Problem 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Unsealed Device Packaging 5 5
Fire 4 4
Material Disintegration 4 4
Component Missing 4 4
Material Frayed 3 3
Material Fragmentation 3 3
Material Separation 3 3
Leak/Splash 2 2
Material Split, Cut or Torn 2 2
Electrical /Electronic Property Problem 2 2
Loss of or Failure to Bond 2 2
Fluid/Blood Leak 2 2
Sparking 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Burst Container or Vessel 1 1
Crack 1 1
Difficult to Advance 1 1
Contamination 1 1
Scratched Material 1 1
Key or Button Unresponsive/not Working 1 1
Adhesive Too Strong 1 1
Material Too Rigid or Stiff 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Moisture or Humidity Problem 1 1
Packaging Problem 1 1
Electrical Shorting 1 1
Component Misassembled 1 1
Melted 1 1
Corroded 1 1
Deformation Due to Compressive Stress 1 1
Dull, Blunt 1 1
Biocompatibility 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Foreign Body In Patient 11 11
Insufficient Information 5 5
Burn(s) 3 3
Epistaxis 2 2
Impaired Healing 1 1
Superficial (First Degree) Burn 1 1
Wound Dehiscence 1 1
Erythema 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Mar-14-2025
2 American Contract Systems Inc. II Oct-16-2025
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 Sep-03-2026
7 Cardinal Health 200, LLC II Aug-13-2026
8 Cardinal Health 200, LLC II Feb-10-2025
9 Cardinal Health 200, LLC II Jan-15-2025
10 Cardinal Health 200, LLC II Oct-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
14 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
24 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
27 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
28 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
29 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
30 Medline Industries Inc II Jan-07-2021
31 Medline Industries, LP II Aug-26-2026
32 Medline Industries, LP II Aug-21-2026
33 Medline Industries, LP II Jun-17-2026
34 Medline Industries, LP II Jun-12-2026
35 Medline Industries, LP I May-08-2026
36 Medline Industries, LP II May-07-2026
37 Medline Industries, LP II Apr-30-2026
38 Medline Industries, LP II Apr-17-2026
39 Medline Industries, LP II Apr-17-2026
40 Medline Industries, LP I Apr-07-2026
41 Medline Industries, LP II Apr-01-2026
42 Medline Industries, LP II Feb-20-2026
43 Medline Industries, LP II Feb-17-2026
44 Medline Industries, LP II Jan-28-2026
45 Medline Industries, LP II Jan-12-2026
46 Medline Industries, LP II Nov-14-2025
47 Medline Industries, LP I Nov-13-2025
48 ROi CPS LLC II Nov-23-2022
49 ROi CPS LLC II Jan-10-2022
50 ROi CPS LLC II Nov-18-2021
51 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
52 Windstone Medical Packaging, Inc. II Jul-24-2026
53 Windstone Medical Packaging, Inc. I Jul-01-2026
54 Windstone Medical Packaging, Inc. II Oct-08-2024
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