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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

Device Problems
Leak/Splash 332
Trocar 176
Valve(s) 119
Cannula 57
Device Operates Differently Than Expected 34
Knife 30
Dull, Blunt 28
Insufficient Information 19
Break 19
Material Integrity Problem 16
Adverse Event Without Identified Device or Use Problem 16
Fluid Leak 11
Device Contamination with Chemical or Other Material 10
Material Fragmentation 10
Manufacturing, Packaging or Shipping Problem 7
Device Misassembled During Manufacturing /Shipping 7
Device Contaminated During Manufacture or Shipping 7
Detachment Of Device Component 5
Air Leak 5
Improper or Incorrect Procedure or Method 3
Material Perforation 3
Difficult to Insert 3
Port 3
Sticking 3
Mechanical Problem 3
Tip 3
Bent 3
Use of Device Problem 3
Device Dislodged or Dislocated 3
Material Too Rigid or Stiff 2
Failure to Advance 2
Material Puncture/Hole 2
Defective Device 2
Packaging Problem 2
Off-Label Use 2
Detachment of Device or Device Component 2
Physical Resistance/Sticking 2
Contamination /Decontamination Problem 2
Degraded 2
Fiber 2
Probe 2
Difficult to Remove 2
Device Inoperable 2
Component Missing 2
Misfire 2
Pressure Problem 2
Appropriate Term/Code Not Available 2
Loose or Intermittent Connection 1
Difficult to Open or Close 1
Incorrect Device Or Component Shipped 1
Material Protrusion/Extrusion 1
Fire 1
Flaked 1
Hole In Material 1
Lead(s), breakage of 1
Device Slipped 1
Temperature Problem 1
Guide 1
Switch, Push Button 1
Noise, Audible 1
Kinked 1
Material Frayed 1
Contamination 1
Electrical /Electronic Property Problem 1
Mechanical Jam 1
Fitting Problem 1
Tear, Rip or Hole in Device Packaging 1
Material Separation 1
Screw 1
Cutter/Blade 1
Crack 1
Physical Resistance 1
Human Factors Issue 1
Positioning Problem 1
Component Misassembled 1
Device Reprocessing Problem 1
Cut In Material 1
Material Twisted/Bent 1
Component Falling 1
Continuous Firing 1
Incorrect Measurement 1
Device Issue 1
Aspiration Issue 1
Failure to Clean Adequately 1
Tube 1
Total Device Problems 1012

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LTD. II Aug-25-2017
2 Alcon Research, Ltd. II Oct-30-2015
3 Alcon Research, Ltd. II Jun-09-2015
4 American Contract Systems II May-29-2020
5 Avid Medical, Inc. II Mar-19-2020
6 Avid Medical, Inc. II Feb-28-2018
7 Avid Medical, Inc. II Feb-09-2018
8 Avid Medical, Inc. II Aug-18-2016
9 Cardinal Health 200, LLC II Feb-03-2020
10 Cardinal Health 200, LLC II Aug-14-2017
11 Cardinal Health Inc. II Jan-09-2019
12 Centurion Medical Products Corporation II Feb-05-2020
13 Centurion Medical Products Corporation II Nov-06-2019
14 Centurion Medical Products Corporation II Oct-31-2019
15 Centurion Medical Products Corporation II Jan-08-2015
16 Covidien LLC II Nov-08-2016
17 Custom Assemblies Inc II Aug-22-2017
18 Custom Healthcare Systems, Inc. II Jan-24-2020
19 Custom Healthcare Systems, Inc. II Oct-25-2018
20 Customed, Inc II Apr-14-2016
21 Customed, Inc II Sep-03-2015
22 DeRoyal Industries Inc II Jul-16-2019
23 DeRoyal Industries Inc II Feb-16-2018
24 DeRoyal Industries Inc II Jan-12-2018
25 DeRoyal Industries Inc II Dec-06-2017
26 DeRoyal Industries Inc III Feb-23-2017
27 DeRoyal Industries Inc II Aug-26-2016
28 DeRoyal Industries Inc II Dec-02-2015
29 DeRoyal Industries Inc II Nov-06-2015
30 DeRoyal Industries Inc II Jun-25-2015
31 Encore Medical, Lp II Aug-02-2018
32 Gi Supply II Mar-04-2016
33 Medline Industries Inc II May-15-2020
34 Medline Industries Inc II Mar-20-2020
35 ROi CPS LLC II Jan-30-2020
36 Resource Optimization & Innovation Llc II Nov-21-2017
37 Resource Optimization & Innovation Llc II Mar-24-2017
38 Resource Optimization & Innovation Llc II Nov-05-2015
39 Resource Optimization & Innovation Llc II Sep-21-2015
40 Stradis Healthcare, LLC. II Jul-07-2015
41 Stryker GmbH II Mar-06-2019
42 Windstone Medical Packaging, Inc. II Nov-07-2017

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