Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The u...
FDA Device Recall #Z-2278-2020 — Class II — August 21, 2018
Recall Summary
| Recall Number | Z-2278-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Genicon, Inc. |
| Location | Winter Park, FL |
| Product Type | Devices |
| Quantity | 0 (6 boxes with 5 units/per box in inventory) |
Product Description
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Reason for Recall
There is potential for the plastic optical tip to become detached from the metal shaft.
Distribution Pattern
US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
Lot / Code Information
Lot I8086-C
Other Recalls from Genicon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0310-2021 | Class II | A Li-Gator Single Use Laparoscopic Clip Applier... | Sep 17, 2020 |
| Z-0094-2021 | Class II | Aquas PowerFlow Tube Set - Product Usage: The d... | Aug 25, 2020 |
| Z-2267-2020 | Class II | Genicon GENILook Model 200-005-152, 5mm diamete... | Aug 21, 2018 |
| Z-2275-2020 | Class II | Genicon Natura Model 210-005-152, 5mm diameter,... | Aug 21, 2018 |
| Z-2269-2020 | Class II | Genicon GENILook Model 200-005-251, 5mm diamete... | Aug 21, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.