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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound dressing kit
Regulation Description Elastic bandage.
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 CodeMCY
Regulation Number 880.5075
Device Class 2

MDR Year MDR Reports MDR Events
2020 9 9
2021 3 3
2024 10 10
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Insufficient Information 3 3
Defective Component 3 3
Leak/Splash 2 2
Crack 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2
Loose or Intermittent Connection 2 2
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Device Appears to Trigger Rejection 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Hypersensitivity/Allergic reaction 3 3
Blister 3 3
Rash 3 3
Unspecified Infection 2 2
Impaired Healing 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abrasion 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Code Available 1 1
Itching Sensation 1 1
Foreign Body In Patient 1 1
Scar Tissue 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. I Jan-03-2024
2 Busse Hospital Disposables, Inc. II May-28-2022
3 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
8 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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