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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

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 10 10
Appropriate Term/Code Not Available 10 10
Material Separation 6 6
Break 5 5
Material Fragmentation 5 5
Component Incompatible 4 4
Material Frayed 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Incomplete or Missing Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Loose or Intermittent Connection 2 2
Crack 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
Delivered as Unsterile Product 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 47 47
Insufficient Information 9 9
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 II Dec-30-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
27 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
28 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
29 Medline Industries Inc II Dec-10-2021
30 ROi CPS LLC II Apr-25-2023
31 ROi CPS LLC II Nov-23-2022
32 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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