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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cesarean section tray
Regulation Description Gynecologic laparoscope 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 CodeOHM
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 7 7
2024 32 32
2025 19 19
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 13 13
Patient Device Interaction Problem 8 8
Material Integrity Problem 6 6
Component Missing 5 5
Break 3 3
Delivered as Unsterile Product 3 3
Material Separation 2 2
Suction Problem 2 2
Material Twisted/Bent 2 2
Mechanical Problem 2 2
Packaging Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Rupture 1 1
Contamination 1 1
Crack 1 1
Material Discolored 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Skin Inflammation/ Irritation 10 10
Rash 8 8
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Wound Dehiscence 1 1
Itching Sensation 1 1
Chemical Exposure 1 1
Foreign Body In Patient 1 1
Erythema 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Mar-14-2025
2 American Contract Systems Inc. II Oct-16-2025
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 Cardinal Health 200, LLC II Oct-10-2023
6 DeRoyal Industries Inc II Jun-07-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2025
8 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
9 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Mar-18-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
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-22-2024
16 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
19 Medline Industries, LP II May-07-2026
20 Medline Industries, LP II Feb-17-2026
21 Medline Industries, LP II Jan-28-2026
22 Medline Industries, LP II Nov-14-2025
23 ROi CPS LLC II Apr-25-2023
24 ROi CPS LLC II Jul-19-2022
25 ROi CPS LLC II Apr-26-2022
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