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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
2021 920 924
2022 1134 1142
2023 1913 1921
2024 3031 3039
2025 5558 5558

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 5088 5093
Suction Failure 1461 1462
Suction Problem 1345 1345
Break 630 634
Fluid/Blood Leak 537 541
Leak/Splash 399 399
Material Twisted/Bent 353 355
Obstruction of Flow 349 350
Adverse Event Without Identified Device or Use Problem 328 330
Inability to Irrigate 325 325
Complete Blockage 293 293
Ambient Noise Problem 246 246
Air/Gas in Device 236 236
Infusion or Flow Problem 229 229
No Flow 179 179
Contamination 150 151
Noise, Audible 144 144
Detachment of Device or Device Component 136 138
Appropriate Term/Code Not Available 130 130
Contamination /Decontamination Problem 125 125
Dull, Blunt 114 117
Product Quality Problem 101 101
Improper Flow or Infusion 99 99
Fitting Problem 88 89
Incomplete or Inadequate Connection 88 88
Decrease in Suction 86 87
Loose or Intermittent Connection 81 83
Disconnection 76 76
Failure to Prime 71 71
Particulates 66 66
Defective Component 56 57
Material Separation 55 55
Defective Device 51 51
Material Integrity Problem 49 49
Crack 45 45
Device Contamination with Chemical or Other Material 36 36
Component Missing 31 31
Material Puncture/Hole 29 29
Difficult to Remove 26 26
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Gas/Air Leak 23 23
Packaging Problem 23 23
Material Fragmentation 21 21
Difficult to Insert 20 20
Connection Problem 20 20
Failure to Infuse 19 19
Material Protrusion/Extrusion 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Device Displays Incorrect Message 16 16
Device Contaminated During Manufacture or Shipping 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9603 9626
Insufficient Information 2201 2204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
Intraocular Pressure Decreased 131 131
Endophthalmitis 127 127
Eye Burn 86 87
Capsular Bag Tear 74 74
Toxic Anterior Segment Syndrome (TASS) 74 74
Foreign Body In Patient 53 53
Inflammation 53 53
Retinal Tear 51 51
Corneal Edema 51 51
Eye Injury 45 45
Blurred Vision 45 45
Uveitis 38 38
Retinal Detachment 37 37
Eye Pain 30 30
Intraocular Pressure Increased 27 27
Hypopyon 27 27
Burn(s) 24 24
Vitreous Hemorrhage 22 22
Conjunctivitis 21 21
Corneal Clouding/Hazing 21 21
Hemorrhage/Bleeding 19 19
Rupture 16 16
Wound Dehiscence 16 16
Vitritis 14 14
Retinal Injury 14 16
Visual Disturbances 14 14
Loss of Vision 12 12
Unspecified Infection 12 12
Corneal Abrasion 11 11
Visual Impairment 11 11
Unspecified Eye / Vision Problem 11 11
Corneal Ulcer 10 10
Stroke/CVA 10 10
Foreign Body Sensation in Eye 9 9
Vitreous Floaters 8 8
Red Eye(s) 8 8
Prolapse 8 8
Fibrosis 7 7
Needle Stick/Puncture 7 7
Bacterial Infection 6 6
Hyphema 6 6
Skin Disorders 6 6
Pain 6 6
Iritis 5 5
Cataract 4 4
Keratitis 4 4
Zonular Dehiscence 4 4

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. I Jan-02-2026
2 AVID Medical, Inc. II Dec-15-2025
3 AVID Medical, Inc. II Sep-05-2025
4 AVID Medical, Inc. II Aug-04-2025
5 AVID Medical, Inc. II May-09-2025
6 AVID Medical, Inc. II Nov-14-2024
7 Alcon Research LLC I Dec-23-2025
8 Alcon Research LLC II Jul-10-2025
9 Alcon Research LLC II Mar-06-2025
10 Alcon Research LLC II Aug-16-2024
11 Alcon Research, LLC II Apr-22-2024
12 Alcon Research, LLC II Mar-22-2024
13 Alcon Research, LLC II Nov-07-2023
14 Alcon Research, LLC II Mar-28-2023
15 Alcon Research, LLC II Dec-01-2022
16 Alcon Research, LLC II Jul-12-2022
17 Alcon Research, LLC II Apr-01-2021
18 American Contract Systems Inc II Aug-28-2025
19 American Contract Systems Inc II Mar-14-2025
20 American Contract Systems Inc. II Oct-16-2025
21 American Contract Systems, Inc. II Sep-24-2024
22 American Contract Systems, Inc. II Aug-07-2024
23 American Contract Systems, Inc. II Jan-26-2024
24 American Contract Systems, Inc. II Oct-26-2023
25 American Contract Systems, Inc. II Nov-22-2022
26 American Contract Systems, Inc. II Sep-08-2022
27 Avid Medical, Inc. I Jun-04-2021
28 Cardinal Health 200, LLC II Feb-10-2025
29 Cardinal Health 200, LLC II Jan-15-2025
30 Cardinal Health 200, LLC II Oct-10-2023
31 DeRoyal Industries Inc II Nov-05-2024
32 DeRoyal Industries Inc II Sep-30-2024
33 DeRoyal Industries Inc I Mar-29-2024
34 DeRoyal Industries Inc II Oct-16-2023
35 DeRoyal Industries Inc II Jul-03-2023
36 DeRoyal Industries Inc II Jun-07-2023
37 DeRoyal Industries Inc II Jan-09-2023
38 DeRoyal Industries Inc II Jan-05-2023
39 DeRoyal Industries Inc II Dec-15-2022
40 DeRoyal Industries Inc II Aug-31-2022
41 DeRoyal Industries Inc II Apr-06-2022
42 DeRoyal Industries Inc I Jun-10-2021
43 DeRoyal Industries Inc II Feb-19-2021
44 Deroyal Industries, Inc. Lafollette I Sep-29-2021
45 MEDLINE INDUSTRIES, LP - Northfield I Sep-19-2025
46 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2025
47 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2025
48 MEDLINE INDUSTRIES, LP - Northfield II Jun-30-2025
49 MEDLINE INDUSTRIES, LP - Northfield II Jun-20-2025
50 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
51 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
52 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
53 MEDLINE INDUSTRIES, LP - Northfield I Apr-10-2025
54 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
55 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
56 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
57 MEDLINE INDUSTRIES, LP - Northfield II Feb-19-2025
58 MEDLINE INDUSTRIES, LP - Northfield II Feb-14-2025
59 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
60 MEDLINE INDUSTRIES, LP - Northfield I Jan-29-2025
61 MEDLINE INDUSTRIES, LP - Northfield II Jan-28-2025
62 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
63 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
64 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
65 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
66 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
67 MEDLINE INDUSTRIES, LP - Northfield II Nov-12-2024
68 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
69 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
70 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
71 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
72 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
73 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
74 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
75 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
76 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
77 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
78 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
79 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
80 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
81 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
82 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
83 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
84 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
85 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
86 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
87 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
88 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
89 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
90 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
91 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
92 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
93 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
94 Medical Action Industries, Inc. 306 II Jun-24-2021
95 Medline Industries Inc II Dec-10-2021
96 Medline Industries Inc II Jun-09-2021
97 Medline Industries Inc II Jan-07-2021
98 Medline Industries, LP II Jan-14-2026
99 Medline Industries, LP II Jan-12-2026
100 Medline Industries, LP II Nov-14-2025
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