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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
  1.  K212258  Medline Cardiovascular Procedure Kit
  2.  K213481  Medline General Surgery Tray

MDR Year MDR Reports MDR Events
2020 767 767
2021 920 920
2022 1134 1134
2023 1915 1915
2024 3036 3036
2025 318 318

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 2302 2302
Suction Failure 1184 1184
Fluid/Blood Leak 527 527
Break 507 507
Suction Problem 341 341
Leak/Splash 323 323
Adverse Event Without Identified Device or Use Problem 308 308
Inability to Irrigate 307 307
Complete Blockage 262 262
Material Twisted/Bent 195 195
No Flow 173 173
Air/Gas in Device 151 151
Contamination /Decontamination Problem 143 143
Detachment of Device or Device Component 134 134
Contamination 127 127
Noise, Audible 116 116
Obstruction of Flow 114 114
Infusion or Flow Problem 103 103
Appropriate Term/Code Not Available 95 95
Dull, Blunt 90 90
Decrease in Suction 82 82
Ambient Noise Problem 71 71
Fitting Problem 70 70
Loose or Intermittent Connection 67 67
Particulates 58 58
Disconnection 55 55
Product Quality Problem 53 53
Device Contamination with Chemical or Other Material 45 45
Failure to Prime 43 43
Material Puncture/Hole 39 39
Defective Component 39 39
Improper Flow or Infusion 38 38
Material Separation 37 37
Defective Device 37 37
Material Fragmentation 36 36
Therapeutic or Diagnostic Output Failure 36 36
Material Integrity Problem 35 35
Crack 31 31
Gas/Air Leak 30 30
Component Missing 29 29
Output Problem 28 28
Difficult to Remove 26 26
Difficult to Insert 22 22
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
Connection Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6064 6064
Insufficient Information 957 957
No Consequences Or Impact To Patient 295 295
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 143 143
No Known Impact Or Consequence To Patient 134 134
Endophthalmitis 107 107
Intraocular Pressure Decreased 70 70
Toxic Anterior Segment Syndrome (TASS) 65 65
Foreign Body In Patient 55 55
Capsular Bag Tear 54 54
Eye Burn 53 53
Inflammation 41 41
Uveitis 37 37
Corneal Edema 36 36
Retinal Tear 29 29
Blurred Vision 28 28
No Patient Involvement 27 27
Eye Injury 26 26
Retinal Detachment 25 25
Unspecified Infection 24 24
Burn(s) 20 20
Intraocular Pressure Increased 18 18
Eye Pain 16 16
Vitreous Hemorrhage 16 16
Hypopyon 16 16
Hemorrhage/Bleeding 15 15
Rupture 14 14
Retinal Injury 14 14
Conjunctivitis 14 14
Corneal Clouding/Hazing 12 12
Vitritis 12 12
Loss of Vision 11 11
Corneal Ulcer 9 9
Visual Impairment 9 9
Foreign Body Sensation in Eye 9 9
Corneal Abrasion 8 8
Visual Disturbances 7 7
Bacterial Infection 7 7
Fibrosis 7 7
Vitreous Floaters 7 7
Unspecified Eye / Vision Problem 7 7
Pain 7 7
Wound Dehiscence 7 7
Fluid Discharge 5 5
Needle Stick/Puncture 5 5
Prolapse 5 5
Device Embedded In Tissue or Plaque 5 5
Hyphema 5 5
Red Eye(s) 4 4
Vitreous Loss 4 4

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