ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamor...

FDA Device Recall #Z-0648-2021 — Class II — November 3, 2020

Recall Summary

Recall Number Z-0648-2021
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 100,000 units

Product Description

ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

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: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384

Other Recalls from GA HEALTH COMPANY LIMITED

Recall # Classification Product Date
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-0643-2021 Class II Andorate Disposable Endoscope Valves Set-Contai... 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.