InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Product...
FDA Device Recall #Z-0675-2016 — Class II — January 5, 2016
Recall Summary
| Recall Number | Z-0675-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Rymed Technologies, LLC |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | 496,400 units |
Product Description
InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
Reason for Recall
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
Distribution Pattern
US Nationwide Distribution.
Lot / Code Information
InVision-Plus Catalog number RYM-5000 Lots 610, 611, 613, 614; Catalog number RYM-5001 Lots R01777, R01789, R01807, R01817, R01822, R01827, R01839, R01848, R01857, R01860, R01871, and R01874; Catalog number RYM-5001CL Lots R01825, R01887, and R01890. InVision Plus Junior Catalog number RYM-8001 Lot R01853.
Other Recalls from Rymed Technologies, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0676-2016 | Class II | InVision-Plus CS Needleless IV Connector, Catal... | Jan 5, 2016 |
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.