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
| Device Type ID | 5726 |
| Device Name | General Surgery Tray |
| Physical State | 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 |
| Technical Method | 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 |
| Target Area | 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 |
| Regulation Description | Surgical Drape And Drape Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LRO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5726 |
| Device | General Surgery Tray |
| Product Code | LRO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 333 |
Trocar | 180 |
Valve | 120 |
Cannula | 57 |
Device Operates Differently Than Expected | 34 |
Knife | 34 |
Dull, Blunt | 32 |
Insufficient Information | 18 |
Break | 14 |
Fluid Leak | 12 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Material Integrity Problem | 10 |
Device Contamination With Chemical Or Other Material | 10 |
Device Contaminated During Manufacture Or Shipping | 6 |
Detachment Of Device Component | 6 |
Material Fragmentation | 6 |
Air Leak | 5 |
Device Misassembled During Manufacturing / Shipping | 4 |
Probe | 4 |
Tip | 4 |
Device Dislodged Or Dislocated | 3 |
Port | 3 |
Bent | 3 |
Detachment Of Device Or Device Component | 3 |
Mechanical Problem | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Difficult To Insert | 3 |
Sticking | 3 |
Fitting Problem | 3 |
Pressure Problem | 2 |
Off-Label Use | 2 |
Material Too Rigid Or Stiff | 2 |
Fiber | 2 |
Material Perforation | 2 |
Packaging Problem | 2 |
Difficult To Remove | 2 |
Failure To Advance | 2 |
Device Inoperable | 2 |
Component Missing | 2 |
Degraded | 2 |
Appropriate Term/Code Not Available | 2 |
Misfire | 2 |
Continuous Firing | 1 |
Electrical /Electronic Property Problem | 1 |
Material Frayed | 1 |
Component Misassembled | 1 |
Incorrect Measurement | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Obstruction Of Flow | 1 |
Difficult To Open Or Close | 1 |
Screw | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Contamination During Use | 1 |
Physical Resistance | 1 |
Fire | 1 |
Material Twisted / Bent | 1 |
Cutter | 1 |
Temperature Problem | 1 |
Improper Flow Or Infusion | 1 |
Noise, Audible | 1 |
Cut In Material | 1 |
Defective Device | 1 |
Crack | 1 |
Nonstandard Device | 1 |
Device Slipped | 1 |
Component Falling | 1 |
Flaked | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Positioning Problem | 1 |
Switch, Push Button | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Material Protrusion / Extrusion | 1 |
Mechanical Jam | 1 |
Tube | 1 |
Hole In Material | 1 |
Incorrect Device Or Component Shipped | 1 |
Aspiration Issue | 1 |
Guide | 1 |
Lead(s), Breakage Of | 1 |
| Total Device Problems | 994 |
| 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 | Alcon Research, Ltd. | II | Jun-30-2014 |
| 5 | Avid Medical, Inc. | II | Feb-28-2018 |
| 6 | Avid Medical, Inc. | II | Feb-09-2018 |
| 7 | Avid Medical, Inc. | II | Aug-18-2016 |
| 8 | Biomet 3i, LLC | II | Mar-12-2014 |
| 9 | Cardinal Health 200, LLC | II | Aug-14-2017 |
| 10 | Cardinal Health Inc. | II | Jan-09-2019 |
| 11 | Centurion Medical Products Corporation | II | Jan-08-2015 |
| 12 | Covidien LLC | II | Nov-08-2016 |
| 13 | Custom Assemblies Inc | II | Aug-22-2017 |
| 14 | Custom Healthcare Systems, Inc. | II | Oct-25-2018 |
| 15 | Customed, Inc | II | Apr-14-2016 |
| 16 | Customed, Inc | II | Sep-03-2015 |
| 17 | Customed, Inc | I | Dec-16-2014 |
| 18 | Customed, Inc | I | Aug-29-2014 |
| 19 | DeRoyal Industries Inc | II | Feb-16-2018 |
| 20 | DeRoyal Industries Inc | II | Jan-12-2018 |
| 21 | DeRoyal Industries Inc | II | Dec-06-2017 |
| 22 | DeRoyal Industries Inc | III | Feb-23-2017 |
| 23 | DeRoyal Industries Inc | II | Aug-26-2016 |
| 24 | DeRoyal Industries Inc | II | Dec-02-2015 |
| 25 | DeRoyal Industries Inc | II | Nov-06-2015 |
| 26 | DeRoyal Industries Inc | II | Jun-25-2015 |
| 27 | DeRoyal Industries Inc | II | Jul-29-2014 |
| 28 | Encore Medical, Lp | II | Aug-02-2018 |
| 29 | Gi Supply | II | Mar-04-2016 |
| 30 | Medline Industries, Inc. | I | Feb-21-2014 |
| 31 | Resource Optimization & Innovation Llc | II | Nov-21-2017 |
| 32 | Resource Optimization & Innovation Llc | II | Mar-24-2017 |
| 33 | Resource Optimization & Innovation Llc | II | Nov-05-2015 |
| 34 | Resource Optimization & Innovation Llc | II | Sep-21-2015 |
| 35 | Stradis Healthcare, LLC. | II | Jul-07-2015 |
| 36 | Stryker GmbH | II | Mar-06-2019 |
| 37 | Windstone Medical Packaging, Inc. | II | Nov-07-2017 |