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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological tray
Regulation Description Microsurgical instrument.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 9 9
2022 11 11
2023 9 9
2024 39 39
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 11 11
Appropriate Term/Code Not Available 11 11
Material Separation 6 6
Break 5 5
Material Fragmentation 5 5
Contamination /Decontamination Problem 4 4
Component Incompatible 4 4
Material Frayed 3 3
Material Integrity Problem 3 3
Incomplete or Missing Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Delivered as Unsterile Product 2 2
Device Contamination with Chemical or Other Material 2 2
Loose or Intermittent Connection 2 2
Crack 1 1
Device Damaged Prior to Use 1 1
Filling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Inaccurate Flow Rate 1 1
Device Damaged by Another Device 1 1
Packaging Problem 1 1
Unexpected Color 1 1
Product Quality Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Insufficient Information 10 10
Foreign Body In Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Local Reaction 3 3
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Sleep Dysfunction 1 1
Dyspnea 1 1
Headache 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-20-2025
3 American Contract Systems Inc II Mar-14-2025
4 American Contract Systems, Inc. II Sep-24-2024
5 American Contract Systems, Inc. II Aug-07-2024
6 American Contract Systems, Inc. II Jan-26-2024
7 American Contract Systems, Inc. II Sep-08-2022
8 American Contract Systems, Inc. II May-06-2022
9 Avid Medical, Inc. II Mar-19-2020
10 Cardinal Health 200, LLC II Feb-10-2025
11 Cardinal Health 200, LLC II Jan-15-2025
12 Cardinal Health 200, LLC II Jul-10-2024
13 Cardinal Health 200, LLC II Oct-10-2023
14 Integra LifeSciences Corp. II Mar-22-2022
15 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
16 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
17 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
18 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
29 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
30 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
31 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
32 Medline Industries Inc II Dec-10-2021
33 ROi CPS LLC II Apr-25-2023
34 ROi CPS LLC II Nov-23-2022
35 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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