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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
2021 2 2
2022 9 9
2023 5 5
2024 14 14
2025 10 10
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 12 12
Appropriate Device Problem Term/Code Not Available 5 5
Leak/Splash 3 3
Sparking 3 3
Defective Device 3 3
Material Integrity Problem 2 2
Component Missing 2 2
Decrease in Pressure 2 2
Fluid/Blood Leak 2 2
Extra Components 2 2
Material Frayed 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Decrease in Suction 1 1
Inflation Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 10 10
Hemorrhage/Blood Loss/Bleeding 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Aug-28-2025
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems Inc. II Oct-16-2025
4 American Contract Systems, Inc. II Sep-24-2024
5 American Contract Systems, Inc. II Jan-26-2024
6 American Contract Systems, Inc. II Sep-08-2022
7 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
8 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
9 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
18 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
22 Medline Industries, LP II Aug-31-2026
23 Medline Industries, LP II Aug-31-2026
24 Medline Industries, LP II Jun-29-2026
25 Medline Industries, LP II Jun-17-2026
26 Medline Industries, LP II Jun-12-2026
27 Medline Industries, LP II May-07-2026
28 Medline Industries, LP II Apr-17-2026
29 Medline Industries, LP I Apr-07-2026
30 Medline Industries, LP II Feb-17-2026
31 Medline Industries, LP II Nov-14-2025
32 ROi CPS LLC I Feb-04-2025
33 ROi CPS LLC II Apr-25-2023
34 ROi CPS LLC II Apr-26-2022
35 ROi CPS LLC II Dec-22-2021
36 ROi CPS LLC II Nov-18-2021
37 ROi CPS LLC II Jul-30-2021
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