Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-...
FDA Device Recall #Z-0113-2015 — Class II — August 28, 2014
Recall Summary
| Recall Number | Z-0113-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 28, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vygon Corporation |
| Location | Lansdale, PA |
| Product Type | Devices |
| Quantity | 42250 |
Product Description
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Reason for Recall
Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
Distribution Pattern
Worldwide Distribution - US including CA and Internationally to CA.
Lot / Code Information
Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.
Other Recalls from Vygon Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0937-2013 | Class II | Churchill Medical Systems, Inc. A Vygon Company... | Dec 17, 2012 |
| Z-1797-2012 | Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, ... | May 11, 2012 |
| Z-1808-2012 | Class II | Churchill Medical Systems, Inc. A VYGON COMPANY... | May 11, 2012 |
| Z-1807-2012 | Class II | Churchill Medical Systems, Inc. DRESSING CHANGE... | May 11, 2012 |
| Z-1800-2012 | Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, ... | May 11, 2012 |
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.