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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plastic surgery and accessories kit
Regulation Description Plastic surgery kit and accessories.
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 CodeFTN
Regulation Number 878.3925
Device Class 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 2 2
2023 9 9
2024 26 26
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 7 7
Appropriate Term/Code Not Available 3 3
Break 3 3
Contamination 3 3
Leak/Splash 2 2
Detachment of Device or Device Component 2 2
Gas/Air Leak 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Particulates 1 1
Product Quality Problem 1 1
Suction Problem 1 1
Sparking 1 1
Contamination /Decontamination Problem 1 1
Disconnection 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Material Fragmentation 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
Foreign Body In Patient 7 7
Insufficient Information 3 3
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
Fatigue 1 1
Unspecified Gastrointestinal Problem 1 1
Pyrosis/Heartburn 1 1
Needle Stick/Puncture 1 1
Vertigo 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Oct-26-2023
3 American Contract Systems, Inc. II Sep-08-2022
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
7 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
15 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
20 Medline Industries, LP II May-07-2026
21 Medline Industries, LP II Apr-30-2026
22 Medline Industries, LP II Apr-17-2026
23 Medline Industries, LP II Apr-17-2026
24 Medline Industries, LP I Apr-07-2026
25 Medline Industries, LP II Feb-17-2026
26 Medline Industries, LP II Jan-28-2026
27 Medline Industries, LP II Jan-12-2026
28 Medline Industries, LP II Nov-14-2025
29 Medline Industries, LP I Nov-13-2025
30 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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