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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
Regulation Description Surgical drape and drape 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 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 3033 3033
2025 1186 1186

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 2687 2687
Suction Failure 1297 1297
Break 564 564
Fluid/Blood Leak 535 535
Suction Problem 456 456
Leak/Splash 371 371
Inability to Irrigate 320 320
Adverse Event Without Identified Device or Use Problem 311 311
Complete Blockage 283 283
Material Twisted/Bent 230 230
No Flow 179 179
Air/Gas in Device 162 162
Obstruction of Flow 155 155
Contamination /Decontamination Problem 144 144
Detachment of Device or Device Component 137 137
Contamination 133 133
Infusion or Flow Problem 123 123
Noise, Audible 121 121
Appropriate Term/Code Not Available 103 103
Dull, Blunt 100 100
Ambient Noise Problem 94 94
Decrease in Suction 84 84
Fitting Problem 77 77
Loose or Intermittent Connection 71 71
Product Quality Problem 66 66
Particulates 60 60
Disconnection 59 59
Improper Flow or Infusion 57 57
Device Contamination with Chemical or Other Material 46 46
Failure to Prime 45 45
Defective Component 41 41
Material Puncture/Hole 40 40
Defective Device 40 40
Material Integrity Problem 39 39
Material Separation 38 38
Material Fragmentation 37 37
Therapeutic or Diagnostic Output Failure 36 36
Crack 35 35
Gas/Air Leak 32 32
Component Missing 29 29
Output Problem 28 28
Difficult to Remove 26 26
Incomplete or Inadequate Connection 25 25
Difficult to Insert 22 22
Device Displays Incorrect Message 21 21
Packaging Problem 21 21
Physical Resistance/Sticking 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Pressure Problem 19 19
Connection Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6755 6755
Insufficient Information 1105 1105
No Consequences Or Impact To Patient 295 295
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
No Known Impact Or Consequence To Patient 134 134
Endophthalmitis 110 110
Intraocular Pressure Decreased 79 79
Toxic Anterior Segment Syndrome (TASS) 66 66
Eye Burn 60 60
Foreign Body In Patient 56 56
Capsular Bag Tear 56 56
Inflammation 42 42
Corneal Edema 39 39
Uveitis 37 37
Blurred Vision 32 32
Retinal Tear 30 30
Eye Injury 28 28
Retinal Detachment 27 27
No Patient Involvement 27 27
Unspecified Infection 26 26
Eye Pain 22 22
Intraocular Pressure Increased 21 21
Burn(s) 20 20
Hypopyon 19 19
Vitreous Hemorrhage 16 16
Hemorrhage/Bleeding 15 15
Conjunctivitis 15 15
Rupture 14 14
Retinal Injury 14 14
Corneal Clouding/Hazing 13 13
Loss of Vision 12 12
Vitritis 12 12
Corneal Abrasion 11 11
Corneal Ulcer 10 10
Visual Impairment 10 10
Unspecified Eye / Vision Problem 10 10
Foreign Body Sensation in Eye 9 9
Wound Dehiscence 8 8
Visual Disturbances 8 8
Bacterial Infection 7 7
Vitreous Floaters 7 7
Fibrosis 7 7
Pain 7 7
Hyphema 5 5
Fluid Discharge 5 5
Prolapse 5 5
Device Embedded In Tissue or Plaque 5 5
Needle Stick/Puncture 5 5
Red Eye(s) 4 4
Keratitis 4 4

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