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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device labor and delivery kit
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 CodeMLS
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 1 1
2020 3 3
2021 2 2
2022 9 9
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 9 9
Material Split, Cut or Torn 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Packaging Problem 2 2
Decrease in Pressure 2 2
Improper or Incorrect Procedure or Method 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Contamination 1 1
Disconnection 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 5 5
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Sep-08-2022
3 Customed, Inc II Sep-03-2015
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
8 ROi CPS LLC II Apr-25-2023
9 ROi CPS LLC II Apr-26-2022
10 ROi CPS LLC II Dec-22-2021
11 ROi CPS LLC II Nov-18-2021
12 ROi CPS LLC II Jul-30-2021
13 ROi CPS LLC II Dec-02-2020
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