Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve ...
FDA Device Recall #Z-0643-2021 — Class II — November 3, 2020
Recall Summary
| Recall Number | Z-0643-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 3, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GA HEALTH COMPANY LIMITED |
| Location | Shatin N.T., N/A |
| Product Type | Devices |
| Quantity | 6,470 units |
Product Description
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
Reason for Recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Distribution Pattern
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Lot / Code Information
Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229
Other Recalls from GA HEALTH COMPANY LIMITED
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0648-2021 | Class II | ScopeValet Guardian Disposable Endoscope Valves... | Nov 3, 2020 |
| Z-0645-2021 | Class II | Andorate Disposable Endoscope Valves Set-5-piec... | Nov 3, 2020 |
| Z-0641-2021 | Class II | STOPCON Disposable Endoscope Valves Set-Single ... | Nov 3, 2020 |
| Z-0644-2021 | Class II | Andorate Disposable Endoscope Valves Set-Contai... | Nov 3, 2020 |
| Z-0647-2021 | Class II | Bulldog Disposable Endoscope Valves Set-Air/Wat... | Nov 3, 2020 |
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.