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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 5555 5555
2026 2810 2810

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 6660 6665
Suction Problem 2157 2157
Suction Failure 1469 1470
Break 702 706
Fluid/Blood Leak 557 561
Leak/Splash 461 461
Obstruction of Flow 458 459
Material Twisted/Bent 446 448
Adverse Event Without Identified Device or Use Problem 365 367
Inability to Irrigate 327 327
Infusion or Flow Problem 312 312
Ambient Noise Problem 306 306
Complete Blockage 294 294
Air/Gas in Device 281 281
No Flow 179 179
Contamination 166 167
Incomplete or Inadequate Connection 154 154
Noise, Audible 146 146
Improper Flow or Infusion 144 144
Appropriate Term/Code Not Available 143 143
Detachment of Device or Device Component 141 143
Dull, Blunt 129 132
Contamination /Decontamination Problem 129 129
Product Quality Problem 115 115
Fitting Problem 90 91
Decrease in Suction 86 87
Failure to Prime 85 85
Loose or Intermittent Connection 85 87
Disconnection 82 82
Material Separation 69 69
Particulates 66 66
Defective Device 61 61
Defective Component 61 62
Material Integrity Problem 57 57
Crack 49 49
Device Contamination with Chemical or Other Material 40 40
Material Puncture/Hole 35 35
Component Missing 33 33
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Difficult to Remove 27 27
Packaging Problem 24 24
Gas/Air Leak 24 24
Material Fragmentation 23 23
Connection Problem 21 21
Delivered as Unsterile Product 20 20
Difficult to Insert 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Tear, Rip or Hole in Device Packaging 20 20
Failure to Infuse 19 19
Device Contaminated During Manufacture or Shipping 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11709 11732
Insufficient Information 2839 2842
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
Intraocular Pressure Decreased 144 144
Endophthalmitis 127 127
Toxic Anterior Segment Syndrome (TASS) 103 103
Eye Burn 91 92
Capsular Bag Tear 82 82
Retinal Tear 62 62
Foreign Body In Patient 60 60
Corneal Edema 59 59
Inflammation 56 56
Blurred Vision 49 49
Eye Injury 48 48
Retinal Detachment 39 39
Uveitis 38 38
Eye Pain 30 30
Hypopyon 30 30
Intraocular Pressure Increased 28 28
Burn(s) 26 26
Vitreous Hemorrhage 24 24
Wound Dehiscence 23 23
Corneal Clouding/Hazing 22 22
Conjunctivitis 21 21
Hemorrhage/Bleeding 20 20
Rupture 16 16
Stroke/CVA 15 15
Loss of Vision 14 14
Vitritis 14 14
Retinal Injury 14 16
Unspecified Eye / Vision Problem 14 14
Visual Disturbances 14 14
Vitreous Floaters 12 12
Unspecified Infection 12 12
Corneal Abrasion 11 11
Prolapse 11 11
Visual Impairment 11 11
Corneal Ulcer 10 10
Foreign Body Sensation in Eye 9 9
Red Eye(s) 8 8
Hyphema 7 7
Fibrosis 7 7
Needle Stick/Puncture 7 7
Bacterial Infection 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. II Jun-11-2026
2 AVID Medical, Inc. I May-01-2026
3 AVID Medical, Inc. II Feb-09-2026
4 AVID Medical, Inc. I Jan-02-2026
5 AVID Medical, Inc. II Dec-15-2025
6 AVID Medical, Inc. II Sep-05-2025
7 AVID Medical, Inc. II Aug-04-2025
8 AVID Medical, Inc. II May-09-2025
9 AVID Medical, Inc. II Nov-14-2024
10 Alcon Research LLC I Dec-23-2025
11 Alcon Research LLC II Jul-10-2025
12 Alcon Research LLC II Mar-06-2025
13 Alcon Research LLC II Aug-16-2024
14 Alcon Research, LLC II Apr-22-2024
15 Alcon Research, LLC II Mar-22-2024
16 Alcon Research, LLC II Nov-07-2023
17 Alcon Research, LLC II Mar-28-2023
18 Alcon Research, LLC II Dec-01-2022
19 Alcon Research, LLC II Jul-12-2022
20 Alcon Research, LLC II Apr-01-2021
21 American Contract Systems Inc I May-06-2026
22 American Contract Systems Inc II Aug-28-2025
23 American Contract Systems Inc II Mar-14-2025
24 American Contract Systems Inc. II Oct-16-2025
25 American Contract Systems, Inc. II Sep-24-2024
26 American Contract Systems, Inc. II Aug-07-2024
27 American Contract Systems, Inc. II Jan-26-2024
28 American Contract Systems, Inc. II Oct-26-2023
29 American Contract Systems, Inc. II Nov-22-2022
30 American Contract Systems, Inc. II Sep-08-2022
31 Avid Medical, Inc. I Jun-04-2021
32 Cardinal Health 200, LLC II Feb-10-2025
33 Cardinal Health 200, LLC II Jan-15-2025
34 Cardinal Health 200, LLC II Oct-10-2023
35 DeRoyal Industries Inc II Nov-05-2024
36 DeRoyal Industries Inc II Sep-30-2024
37 DeRoyal Industries Inc I Mar-29-2024
38 DeRoyal Industries Inc II Oct-16-2023
39 DeRoyal Industries Inc II Jul-03-2023
40 DeRoyal Industries Inc II Jun-07-2023
41 DeRoyal Industries Inc II Jan-09-2023
42 DeRoyal Industries Inc II Jan-05-2023
43 DeRoyal Industries Inc II Dec-15-2022
44 DeRoyal Industries Inc II Aug-31-2022
45 DeRoyal Industries Inc II Apr-06-2022
46 DeRoyal Industries Inc I Jun-10-2021
47 DeRoyal Industries Inc II Feb-19-2021
48 Deroyal Industries, Inc. Lafollette I Sep-29-2021
49 MEDLINE INDUSTRIES, LP - Northfield I Sep-19-2025
50 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2025
51 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2025
52 MEDLINE INDUSTRIES, LP - Northfield II Jun-30-2025
53 MEDLINE INDUSTRIES, LP - Northfield II Jun-20-2025
54 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
55 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
56 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
57 MEDLINE INDUSTRIES, LP - Northfield I Apr-10-2025
58 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
59 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
60 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
61 MEDLINE INDUSTRIES, LP - Northfield II Feb-19-2025
62 MEDLINE INDUSTRIES, LP - Northfield II Feb-14-2025
63 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
64 MEDLINE INDUSTRIES, LP - Northfield I Jan-29-2025
65 MEDLINE INDUSTRIES, LP - Northfield II Jan-28-2025
66 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
67 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
68 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
69 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
70 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
71 MEDLINE INDUSTRIES, LP - Northfield II Nov-12-2024
72 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
73 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
74 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
75 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
76 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
77 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
78 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
79 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
80 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
81 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
82 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
83 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
84 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
85 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
86 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
87 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
88 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
89 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
90 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
91 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
92 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
93 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
94 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
95 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
96 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
97 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
98 Medical Action Industries, Inc. 306 I May-06-2026
99 Medical Action Industries, Inc. 306 II Jun-24-2021
100 Medline Industries Inc II Dec-10-2021
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