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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRP
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 10 10
2023 8 8
2024 20 20
2025 13 13
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 4 4
Material Integrity Problem 3 3
Leak/Splash 3 3
Material Discolored 3 3
Residue After Decontamination 3 3
Peeled/Delaminated 2 2
Retraction Problem 2 2
Material Separation 2 2
Unraveled Material 2 2
Difficult to Flush 2 2
Crack 2 2
Material Twisted/Bent 2 2
Output Problem 1 1
Insufficient Information 1 1
Material Too Soft/Flexible 1 1
Sharp Edges 1 1
Loose or Intermittent Connection 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination 1 1
Entrapment of Device 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Component Missing 1 1
Dent in Material 1 1
Defective Device 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Foreign Body In Patient 7 7
Insufficient Information 6 6
Skin Inflammation/ Irritation 4 4
Skin Disorders 2 2
Needle Stick/Puncture 2 2
Laceration(s) 2 2
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Feb-10-2025
2 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
4 MEDLINE INDUSTRIES, LP - Northfield I Jan-29-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Jan-28-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Dec-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
14 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
16 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
21 Medline Industries Inc. II Sep-07-2022
22 Medline Industries, LP II May-07-2026
23 Medline Industries, LP II Apr-30-2026
24 Medline Industries, LP II Apr-30-2026
25 Medline Industries, LP II Feb-17-2026
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