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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
2019 406 406
2020 767 767
2021 920 920
2022 1134 1134
2023 1915 1915
2024 1899 1899

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1791 1791
Suction Failure 903 903
Fluid/Blood Leak 520 520
Break 474 474
Adverse Event Without Identified Device or Use Problem 321 321
Leak/Splash 285 285
Inability to Irrigate 257 257
Suction Problem 245 245
Contamination /Decontamination Problem 210 210
Complete Blockage 181 181
No Flow 146 146
Detachment of Device or Device Component 143 143
Material Twisted/Bent 134 134
Contamination 126 126
Air/Gas in Device 126 126
Noise, Audible 100 100
Dull, Blunt 82 82
Appropriate Term/Code Not Available 80 80
Obstruction of Flow 75 75
Device Contamination with Chemical or Other Material 73 73
Decrease in Suction 72 72
Material Fragmentation 66 66
Fitting Problem 65 65
Infusion or Flow Problem 64 64
Loose or Intermittent Connection 61 61
Particulates 51 51
Product Quality Problem 49 49
Disconnection 47 47
Material Puncture/Hole 45 45
Material Integrity Problem 43 43
Therapeutic or Diagnostic Output Failure 38 38
Defective Component 35 35
Material Separation 35 35
Defective Device 34 34
Component Missing 33 33
Ambient Noise Problem 33 33
Failure to Prime 32 32
Difficult to Remove 30 30
Gas/Air Leak 29 29
Crack 29 29
Output Problem 29 29
Physical Resistance/Sticking 28 28
Manufacturing, Packaging or Shipping Problem 27 27
Material Split, Cut or Torn 22 22
Difficult to Insert 21 21
Pressure Problem 20 20
Device Displays Incorrect Message 20 20
Tear, Rip or Hole in Device Packaging 19 19
Improper Flow or Infusion 18 18
Connection Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4971 4971
Insufficient Information 662 662
No Consequences Or Impact To Patient 412 412
No Known Impact Or Consequence To Patient 343 343
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 130 130
Endophthalmitis 107 107
Toxic Anterior Segment Syndrome (TASS) 65 65
Foreign Body In Patient 57 57
Capsular Bag Tear 49 49
No Patient Involvement 46 46
Intraocular Pressure Decreased 46 46
Inflammation 46 46
Eye Burn 43 43
Uveitis 36 36
Unspecified Infection 33 33
Corneal Edema 28 28
Retinal Tear 27 27
Blurred Vision 23 23
Retinal Detachment 21 21
Eye Injury 20 20
Hypopyon 16 16
Eye Pain 16 16
Burn(s) 15 15
Hemorrhage/Bleeding 15 15
Rupture 15 15
Retinal Injury 14 14
Vitreous Hemorrhage 14 14
Intraocular Pressure Increased 14 14
Conjunctivitis 12 12
Device Embedded In Tissue or Plaque 11 11
Visual Impairment 9 9
Vitritis 9 9
Loss of Vision 9 9
Corneal Abrasion 8 8
Foreign Body Sensation in Eye 8 8
Unspecified Eye / Vision Problem 7 7
Fibrosis 7 7
Bacterial Infection 7 7
Corneal Clouding/Hazing 7 7
Visual Disturbances 7 7
Pain 6 6
No Code Available 6 6
Hyphema 6 6
Fluid Discharge 5 5
Wound Dehiscence 5 5
Vitreous Floaters 5 5
Vitreous Loss 5 5
Injury 5 5
Rash 5 5
Laceration(s) 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Aug-16-2024
2 Alcon Research, LLC II Apr-22-2024
3 Alcon Research, LLC II Mar-22-2024
4 Alcon Research, LLC II Nov-07-2023
5 Alcon Research, LLC II Mar-28-2023
6 Alcon Research, LLC II Dec-01-2022
7 Alcon Research, LLC II Jul-12-2022
8 Alcon Research, LLC II Apr-01-2021
9 Alcon Research, LLC II Oct-09-2020
10 American Contract Systems II May-29-2020
11 American Contract Systems, Inc. II Aug-07-2024
12 American Contract Systems, Inc. II Jan-26-2024
13 American Contract Systems, Inc. II Oct-26-2023
14 American Contract Systems, Inc. II Nov-22-2022
15 American Contract Systems, Inc. II Sep-08-2022
16 Avid Medical, Inc. I Jun-04-2021
17 Avid Medical, Inc. II Mar-19-2020
18 Cardinal Health 200, LLC II Oct-10-2023
19 Cardinal Health 200, LLC II Feb-04-2020
20 Cardinal Health 200, LLC II Feb-03-2020
21 Cardinal Health Inc. II Jan-09-2019
22 Centurion Medical Products Corporation II Feb-05-2020
23 Centurion Medical Products Corporation II Nov-06-2019
24 Centurion Medical Products Corporation II Oct-31-2019
25 Custom Healthcare Systems, Inc. II Jan-24-2020
26 DeRoyal Industries Inc I Mar-29-2024
27 DeRoyal Industries Inc II Oct-16-2023
28 DeRoyal Industries Inc II Jul-03-2023
29 DeRoyal Industries Inc II Jun-07-2023
30 DeRoyal Industries Inc II Jan-09-2023
31 DeRoyal Industries Inc II Jan-05-2023
32 DeRoyal Industries Inc II Dec-15-2022
33 DeRoyal Industries Inc II Aug-31-2022
34 DeRoyal Industries Inc II Apr-06-2022
35 DeRoyal Industries Inc I Jun-10-2021
36 DeRoyal Industries Inc II Feb-19-2021
37 DeRoyal Industries Inc II Jul-16-2019
38 Deroyal Industries, Inc. Lafollette I Sep-29-2021
39 Deroyal Industries, Inc. Lafollette II Feb-19-2020
40 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
41 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
42 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
43 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
44 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
45 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
46 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
47 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
48 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
49 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
50 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
51 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
52 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
53 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
54 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
55 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
56 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
57 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
58 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
59 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
60 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
61 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
62 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
63 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
64 Medical Action Industries, Inc. 306 II Jun-24-2021
65 Medline Industries Inc II Dec-10-2021
66 Medline Industries Inc II Jun-09-2021
67 Medline Industries Inc II Jan-07-2021
68 Medline Industries Inc II May-15-2020
69 Medline Industries Inc II Mar-20-2020
70 ROi CPS LLC I Jan-12-2024
71 ROi CPS LLC II Apr-25-2023
72 ROi CPS LLC II Nov-23-2022
73 ROi CPS LLC II Jun-09-2022
74 ROi CPS LLC II Nov-18-2021
75 ROi CPS LLC II Jan-30-2020
76 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
77 Stryker GmbH II Mar-06-2019
78 Wright Medical Technology, Inc. II Aug-13-2020
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