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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
2020 8 8
2021 3 3
2022 3 3
2023 7 7
2024 32 32
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 13 13
Patient Device Interaction Problem 8 8
Component Missing 8 8
Material Integrity Problem 6 6
Break 3 3
Mechanical Problem 2 2
Defective Device 2 2
Material Twisted/Bent 2 2
Delivered as Unsterile Product 2 2
Material Separation 2 2
Device Contamination with Chemical or Other Material 2 2
Suction Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Device Contamination with Body Fluid 1 1
Crack 1 1
Insufficient Information 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Material Discolored 1 1
Failure to Cut 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Temperature Problem 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 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Known Impact Or Consequence To Patient 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 II May-29-2020
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems Inc. II Oct-16-2025
4 American Contract Systems, Inc. II Jan-26-2024
5 American Contract Systems, Inc. II Sep-08-2022
6 Cardinal Health 200, LLC II Oct-10-2023
7 DeRoyal Industries Inc II Jun-07-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2025
9 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Mar-18-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
17 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
20 ROi CPS LLC II Apr-25-2023
21 ROi CPS LLC II Jul-19-2022
22 ROi CPS LLC II Apr-26-2022
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