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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture removal kit
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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeMCZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 4 4
2022 1 1
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
False Positive Result 3 3
Failure to Cut 2 2
Material Twisted/Bent 1 1
Thickening of Material 1 1
Material Separation 1 1
Degraded 1 1
Dull, Blunt 1 1
Fluid/Blood Leak 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 4 4
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
4 Stradis Healthcare II May-25-2022
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