Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device general surgery tray
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
2019 406 406
2020 767 767
2021 920 920
2022 1134 1134
2023 1915 1915
2024 2105 2105

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1850 1850
Suction Failure 933 933
Fluid/Blood Leak 523 523
Break 485 485
Adverse Event Without Identified Device or Use Problem 322 322
Leak/Splash 292 292
Inability to Irrigate 271 271
Suction Problem 261 261
Contamination /Decontamination Problem 212 212
Complete Blockage 195 195
No Flow 153 153
Material Twisted/Bent 152 152
Detachment of Device or Device Component 146 146
Contamination 127 127
Air/Gas in Device 126 126
Noise, Audible 100 100
Dull, Blunt 88 88
Appropriate Term/Code Not Available 83 83
Obstruction of Flow 81 81
Device Contamination with Chemical or Other Material 74 74
Decrease in Suction 72 72
Infusion or Flow Problem 68 68
Fitting Problem 68 68
Material Fragmentation 66 66
Loose or Intermittent Connection 62 62
Particulates 51 51
Product Quality Problem 49 49
Disconnection 47 47
Material Puncture/Hole 45 45
Material Integrity Problem 43 43
Material Separation 38 38
Therapeutic or Diagnostic Output Failure 38 38
Defective Component 36 36
Defective Device 35 35
Ambient Noise Problem 35 35
Component Missing 33 33
Failure to Prime 33 33
Crack 31 31
Difficult to Remove 30 30
Gas/Air Leak 30 30
Output Problem 29 29
Physical Resistance/Sticking 28 28
Manufacturing, Packaging or Shipping Problem 27 27
Improper Flow or Infusion 24 24
Difficult to Insert 24 24
Material Split, Cut or Torn 22 22
Pressure Problem 20 20
Device Displays Incorrect Message 20 20
Tear, Rip or Hole in Device Packaging 19 19
Connection Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5118 5118
Insufficient Information 711 711
No Consequences Or Impact To Patient 412 412
No Known Impact Or Consequence To Patient 343 343
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 131 131
Endophthalmitis 108 108
Toxic Anterior Segment Syndrome (TASS) 65 65
Foreign Body In Patient 57 57
Intraocular Pressure Decreased 54 54
Capsular Bag Tear 50 50
Eye Burn 47 47
Inflammation 47 47
No Patient Involvement 46 46
Uveitis 36 36
Unspecified Infection 33 33
Corneal Edema 28 28
Retinal Tear 27 27
Blurred Vision 23 23
Eye Injury 21 21
Retinal Detachment 21 21
Burn(s) 17 17
Hypopyon 16 16
Eye Pain 16 16
Hemorrhage/Bleeding 15 15
Intraocular Pressure Increased 15 15
Rupture 15 15
Retinal Injury 14 14
Vitreous Hemorrhage 14 14
Conjunctivitis 12 12
Device Embedded In Tissue or Plaque 11 11
Vitritis 10 10
Loss of Vision 10 10
Visual Impairment 9 9
Corneal Ulcer 9 9
Corneal Abrasion 8 8
Corneal Clouding/Hazing 8 8
Foreign Body Sensation in Eye 8 8
Unspecified Eye / Vision Problem 7 7
Fibrosis 7 7
Bacterial Infection 7 7
Visual Disturbances 7 7
Pain 6 6
No Code Available 6 6
Fluid Discharge 6 6
Hyphema 6 6
Wound Dehiscence 5 5
Vitreous Floaters 5 5
Vitreous Loss 5 5
Injury 5 5
Rash 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Aug-16-2024
2 Alcon Research, LLC II Apr-22-2024
3 Alcon Research, LLC II Mar-22-2024
4 Alcon Research, LLC II Nov-07-2023
5 Alcon Research, LLC II Mar-28-2023
6 Alcon Research, LLC II Dec-01-2022
7 Alcon Research, LLC II Jul-12-2022
8 Alcon Research, LLC II Apr-01-2021
9 Alcon Research, LLC II Oct-09-2020
10 American Contract Systems II May-29-2020
11 American Contract Systems, Inc. II Sep-24-2024
12 American Contract Systems, Inc. II Aug-07-2024
13 American Contract Systems, Inc. II Jan-26-2024
14 American Contract Systems, Inc. II Oct-26-2023
15 American Contract Systems, Inc. II Nov-22-2022
16 American Contract Systems, Inc. II Sep-08-2022
17 Avid Medical, Inc. I Jun-04-2021
18 Avid Medical, Inc. II Mar-19-2020
19 Cardinal Health 200, LLC II Oct-10-2023
20 Cardinal Health 200, LLC II Feb-04-2020
21 Cardinal Health 200, LLC II Feb-03-2020
22 Cardinal Health Inc. II Jan-09-2019
23 Centurion Medical Products Corporation II Feb-05-2020
24 Centurion Medical Products Corporation II Nov-06-2019
25 Centurion Medical Products Corporation II Oct-31-2019
26 Custom Healthcare Systems, Inc. II Jan-24-2020
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 II Jul-16-2019
40 Deroyal Industries, Inc. Lafollette I Sep-29-2021
41 Deroyal Industries, Inc. Lafollette II Feb-19-2020
42 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
43 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
44 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
45 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
46 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
47 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
48 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
49 MEDLINE INDUSTRIES, LP - Northfield II Aug-07-2024
50 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
51 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
52 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
53 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
54 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
55 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
56 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
57 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
58 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
59 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
60 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
61 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
62 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
63 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
64 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
65 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
66 Medical Action Industries, Inc. 306 II Jun-24-2021
67 Medline Industries Inc II Dec-10-2021
68 Medline Industries Inc II Jun-09-2021
69 Medline Industries Inc II Jan-07-2021
70 Medline Industries Inc II May-15-2020
71 Medline Industries Inc II Mar-20-2020
72 ROi CPS LLC I Jan-12-2024
73 ROi CPS LLC II Apr-25-2023
74 ROi CPS LLC II Nov-23-2022
75 ROi CPS LLC II Jun-09-2022
76 ROi CPS LLC II Nov-18-2021
77 ROi CPS LLC II Jan-30-2020
78 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
79 Stryker GmbH II Mar-06-2019
80 Windstone Medical Packaging, Inc. II Oct-08-2024
81 Wright Medical Technology, Inc. II Aug-13-2020
-
-