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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
Regulation Description Obstetric-gynecologic specialized manual instrument.
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
2020 3 3
2021 2 2
2022 9 9
2023 5 5
2024 14 14
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 9 9
Material Split, Cut or Torn 8 8
Appropriate Term/Code Not Available 5 5
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 2 2
Decrease in Pressure 2 2
Packaging Problem 2 2
Disconnection 1 1
Mechanical Problem 1 1
Contamination 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Inflation 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 18 18
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Mar-14-2025
2 American Contract Systems, Inc. II Sep-24-2024
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
14 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
18 ROi CPS LLC I Feb-04-2025
19 ROi CPS LLC II Apr-25-2023
20 ROi CPS LLC II Apr-26-2022
21 ROi CPS LLC II Dec-22-2021
22 ROi CPS LLC II Nov-18-2021
23 ROi CPS LLC II Jul-30-2021
24 ROi CPS LLC II Dec-02-2020
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