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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 802 802

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 2516 2516
Suction Failure 1258 1258
Break 534 534
Fluid/Blood Leak 533 533
Suction Problem 403 403
Leak/Splash 347 347
Inability to Irrigate 315 315
Adverse Event Without Identified Device or Use Problem 310 310
Complete Blockage 274 274
Material Twisted/Bent 213 213
No Flow 178 178
Air/Gas in Device 158 158
Contamination /Decontamination Problem 144 144
Detachment of Device or Device Component 136 136
Obstruction of Flow 134 134
Contamination 129 129
Noise, Audible 120 120
Infusion or Flow Problem 113 113
Appropriate Term/Code Not Available 100 100
Dull, Blunt 96 96
Ambient Noise Problem 84 84
Decrease in Suction 82 82
Fitting Problem 73 73
Loose or Intermittent Connection 70 70
Product Quality Problem 59 59
Particulates 59 59
Disconnection 55 55
Improper Flow or Infusion 49 49
Device Contamination with Chemical or Other Material 45 45
Failure to Prime 43 43
Defective Component 41 41
Material Puncture/Hole 40 40
Material Integrity Problem 39 39
Material Separation 38 38
Defective Device 38 38
Therapeutic or Diagnostic Output Failure 36 36
Material Fragmentation 36 36
Gas/Air Leak 32 32
Crack 32 32
Component Missing 29 29
Output Problem 28 28
Difficult to Remove 26 26
Difficult to Insert 22 22
Incomplete or Inadequate Connection 21 21
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6452 6452
Insufficient Information 1038 1038
No Consequences Or Impact To Patient 295 295
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 147 147
No Known Impact Or Consequence To Patient 134 134
Endophthalmitis 109 109
Intraocular Pressure Decreased 75 75
Toxic Anterior Segment Syndrome (TASS) 65 65
Eye Burn 58 58
Foreign Body In Patient 56 56
Capsular Bag Tear 55 55
Inflammation 41 41
Uveitis 37 37
Corneal Edema 37 37
Blurred Vision 31 31
Retinal Tear 30 30
No Patient Involvement 27 27
Unspecified Infection 26 26
Eye Injury 26 26
Retinal Detachment 26 26
Eye Pain 21 21
Burn(s) 20 20
Intraocular Pressure Increased 19 19
Hypopyon 18 18
Vitreous Hemorrhage 16 16
Hemorrhage/Bleeding 15 15
Conjunctivitis 14 14
Retinal Injury 14 14
Rupture 14 14
Vitritis 12 12
Corneal Clouding/Hazing 12 12
Loss of Vision 11 11
Corneal Ulcer 10 10
Corneal Abrasion 10 10
Foreign Body Sensation in Eye 9 9
Unspecified Eye / Vision Problem 9 9
Visual Impairment 9 9
Wound Dehiscence 8 8
Fibrosis 7 7
Bacterial Infection 7 7
Visual Disturbances 7 7
Vitreous Floaters 7 7
Pain 7 7
Device Embedded In Tissue or Plaque 5 5
Needle Stick/Puncture 5 5
Hyphema 5 5
Fluid Discharge 5 5
Prolapse 5 5
Keratitis 4 4
Zonular Dehiscence 4 4

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