Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single...
FDA Device Recall #Z-0289-2017 — Class II — May 18, 2016
Recall Summary
| Recall Number | Z-0289-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | US Endoscopy Group Inc |
| Location | Mentor, OH |
| Product Type | Devices |
| Quantity | 36 units |
Product Description
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Reason for Recall
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
Distribution Pattern
US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Lot / Code Information
Model #: 00711819; Lot 1520268
Other Recalls from US Endoscopy Group Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1011-2019 | Class II | US Endoscopy Padlock Clip defect closure system... | Feb 4, 2019 |
| Z-1416-2017 | Class III | Roth Net Polyp Retrieval | Dec 13, 2016 |
| Z-0001-2016 | Class II | Histolock Resection Device, US Endoscopy. A... | Jul 14, 2015 |
| Z-1453-2015 | Class II | Talon Grasping Device, 160 cm, US endoscopy. U... | Mar 10, 2015 |
| Z-1943-2015 | Class II | Velocity" Biopsy Valve, 25 units per box, P... | Feb 17, 2015 |
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.