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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 13 13
Component Missing 5 5
Patient Device Interaction Problem 5 5
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Defective Device 2 2
Device Contamination with Chemical or Other Material 2 2
Material Separation 2 2
Suction Problem 2 2
Break 2 2
Failure to Cut 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Crack 1 1
Material Fragmentation 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Skin Inflammation/ Irritation 10 10
Insufficient Information 7 7
Rash 5 5
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Wound Dehiscence 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Itching Sensation 1 1
Pain 1 1
Chemical Exposure 1 1
Foreign Body In Patient 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 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 Apr-17-2025
8 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
9 MEDLINE INDUSTRIES, LP - Northfield II Mar-18-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
15 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
18 ROi CPS LLC II Apr-25-2023
19 ROi CPS LLC II Jul-19-2022
20 ROi CPS LLC II Apr-26-2022
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