6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxG...
FDA Device Recall #Z-2329-2016 — Class II — July 13, 2016
Recall Summary
| Recall Number | Z-2329-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 13, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AccessClosure, Inc., A Cardinal Health Company |
| Location | Santa Clara, CA |
| Product Type | Devices |
| Quantity | 55 units |
Product Description
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
Reason for Recall
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Distribution Pattern
US in the states of CA, and MS.
Lot / Code Information
Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
Other Recalls from AccessClosure, Inc., A Cardinal Healt...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0297-2017 | Class II | The PAXWIRE Occlusion Balloon System consists o... | Oct 6, 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.