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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 88 88
2022 41 41
2023 4 4
2024 4 4
2025 2 2
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 105 105
Contamination /Decontamination Problem 7 7
Material Frayed 4 4
Material Puncture/Hole 4 4
Device Contaminated During Manufacture or Shipping 3 3
Adhesive Too Strong 3 3
Break 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Incomplete or Missing Packaging 1 1
Unsealed Device Packaging 1 1
Insufficient Device Problem Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 66 66
No Clinical Signs, Symptoms or Conditions 22 22
Reaction 12 12
Rash 9 9
Foreign Body In Patient 7 7
Skin Inflammation/ Irritation 6 6
No Known Impact Or Consequence To Patient 5 5
Burn(s) 4 4
Abrasion 3 3
Laceration(s) 3 3
Skin Tears 3 3
Not Applicable 2 2
Erythema 2 2
Discomfort 2 2
Contact Dermatitis 2 2
Unspecified Infection 1 1
Fungal Infection 1 1
Abnormal Vaginal Discharge 1 1
Itching Sensation 1 1
Blister 1 1
Insufficient Information 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Pain 1 1
Swelling/ Edema 1 1
Hyperemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
5 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
7 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
8 Medline Industries, LP II Aug-31-2026
9 Medline Industries, LP II Aug-31-2026
10 Medline Industries, LP II Apr-30-2026
11 Medline Industries, LP II Jan-12-2026
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