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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device general surgery tray
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 CodeLRO
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 767 767
2021 920 920
2022 1134 1134
2023 1915 1915
2024 3036 3036

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 2151 2151
Suction Failure 1121 1121
Fluid/Blood Leak 521 521
Break 488 488
Suction Problem 316 316
Leak/Splash 315 315
Adverse Event Without Identified Device or Use Problem 308 308
Inability to Irrigate 301 301
Complete Blockage 252 252
Material Twisted/Bent 184 184
No Flow 169 169
Air/Gas in Device 146 146
Contamination /Decontamination Problem 143 143
Detachment of Device or Device Component 134 134
Contamination 125 125
Noise, Audible 110 110
Obstruction of Flow 109 109
Appropriate Term/Code Not Available 94 94
Infusion or Flow Problem 92 92
Dull, Blunt 89 89
Decrease in Suction 78 78
Fitting Problem 70 70
Loose or Intermittent Connection 67 67
Ambient Noise Problem 65 65
Particulates 54 54
Disconnection 53 53
Product Quality Problem 50 50
Device Contamination with Chemical or Other Material 45 45
Failure to Prime 41 41
Material Puncture/Hole 39 39
Defective Component 38 38
Defective Device 36 36
Therapeutic or Diagnostic Output Failure 36 36
Improper Flow or Infusion 36 36
Material Fragmentation 36 36
Material Separation 35 35
Material Integrity Problem 33 33
Crack 31 31
Component Missing 29 29
Gas/Air Leak 29 29
Output Problem 28 28
Difficult to Remove 26 26
Difficult to Insert 22 22
Packaging Problem 21 21
Physical Resistance/Sticking 20 20
Device Displays Incorrect Message 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Pressure Problem 19 19
Tear, Rip or Hole in Device Packaging 18 18
Connection Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5802 5802
Insufficient Information 906 906
No Consequences Or Impact To Patient 295 295
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 140 140
No Known Impact Or Consequence To Patient 134 134
Endophthalmitis 107 107
Intraocular Pressure Decreased 68 68
Toxic Anterior Segment Syndrome (TASS) 65 65
Foreign Body In Patient 55 55
Capsular Bag Tear 53 53
Eye Burn 52 52
Inflammation 41 41
Uveitis 37 37
Corneal Edema 36 36
Retinal Tear 29 29
No Patient Involvement 27 27
Eye Injury 26 26
Blurred Vision 26 26
Retinal Detachment 25 25
Unspecified Infection 24 24
Burn(s) 19 19
Intraocular Pressure Increased 18 18
Hypopyon 16 16
Vitreous Hemorrhage 16 16
Eye Pain 16 16
Conjunctivitis 14 14
Retinal Injury 14 14
Hemorrhage/Bleeding 14 14
Rupture 14 14
Vitritis 12 12
Corneal Clouding/Hazing 12 12
Loss of Vision 11 11
Corneal Ulcer 9 9
Visual Impairment 9 9
Corneal Abrasion 8 8
Foreign Body Sensation in Eye 8 8
Vitreous Floaters 7 7
Bacterial Infection 7 7
Fibrosis 7 7
Wound Dehiscence 7 7
Visual Disturbances 7 7
Unspecified Eye / Vision Problem 7 7
Pain 7 7
Hyphema 5 5
Fluid Discharge 5 5
Device Embedded In Tissue or Plaque 5 5
Prolapse 5 5
Keratitis 4 4
Zonular Dehiscence 4 4
Red Eye(s) 4 4

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Nov-14-2024
2 Alcon Research LLC II Aug-16-2024
3 Alcon Research, LLC II Apr-22-2024
4 Alcon Research, LLC II Mar-22-2024
5 Alcon Research, LLC II Nov-07-2023
6 Alcon Research, LLC II Mar-28-2023
7 Alcon Research, LLC II Dec-01-2022
8 Alcon Research, LLC II Jul-12-2022
9 Alcon Research, LLC II Apr-01-2021
10 Alcon Research, LLC II Oct-09-2020
11 American Contract Systems II May-29-2020
12 American Contract Systems, Inc. II Sep-24-2024
13 American Contract Systems, Inc. II Aug-07-2024
14 American Contract Systems, Inc. II Jan-26-2024
15 American Contract Systems, Inc. II Oct-26-2023
16 American Contract Systems, Inc. II Nov-22-2022
17 American Contract Systems, Inc. II Sep-08-2022
18 Avid Medical, Inc. I Jun-04-2021
19 Avid Medical, Inc. II Mar-19-2020
20 Cardinal Health 200, LLC II Jan-15-2025
21 Cardinal Health 200, LLC II Oct-10-2023
22 Cardinal Health 200, LLC II Feb-04-2020
23 Cardinal Health 200, LLC II Feb-03-2020
24 Centurion Medical Products Corporation II Feb-05-2020
25 Custom Healthcare Systems, Inc. II Jan-24-2020
26 DeRoyal Industries Inc II Nov-05-2024
27 DeRoyal Industries Inc II Sep-30-2024
28 DeRoyal Industries Inc I Mar-29-2024
29 DeRoyal Industries Inc II Oct-16-2023
30 DeRoyal Industries Inc II Jul-03-2023
31 DeRoyal Industries Inc II Jun-07-2023
32 DeRoyal Industries Inc II Jan-09-2023
33 DeRoyal Industries Inc II Jan-05-2023
34 DeRoyal Industries Inc II Dec-15-2022
35 DeRoyal Industries Inc II Aug-31-2022
36 DeRoyal Industries Inc II Apr-06-2022
37 DeRoyal Industries Inc I Jun-10-2021
38 DeRoyal Industries Inc II Feb-19-2021
39 Deroyal Industries, Inc. Lafollette I Sep-29-2021
40 Deroyal Industries, Inc. Lafollette II Feb-19-2020
41 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
42 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
43 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
44 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
45 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
46 MEDLINE INDUSTRIES, LP - Northfield II Nov-12-2024
47 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
48 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
49 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
50 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
51 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
52 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
53 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
54 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
55 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
56 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
57 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
58 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
59 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
60 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
61 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
62 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
63 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
64 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
65 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
66 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
67 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
68 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
69 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
70 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
71 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
72 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
73 Medical Action Industries, Inc. 306 II Jun-24-2021
74 Medline Industries Inc II Dec-10-2021
75 Medline Industries Inc II Jun-09-2021
76 Medline Industries Inc II Jan-07-2021
77 Medline Industries Inc II May-15-2020
78 Medline Industries Inc II Mar-20-2020
79 ROi CPS LLC I Jan-12-2024
80 ROi CPS LLC II Apr-25-2023
81 ROi CPS LLC II Nov-23-2022
82 ROi CPS LLC II Jun-09-2022
83 ROi CPS LLC II Nov-18-2021
84 ROi CPS LLC II Jan-30-2020
85 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
86 Windstone Medical Packaging, Inc. II Oct-08-2024
87 Wright Medical Technology, Inc. II Aug-13-2020
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