Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Int...
FDA Device Recall #Z-2400-2012 — Class II — August 30, 2012
Recall Summary
| Recall Number | Z-2400-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 30, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vascular Solutions, Inc. |
| Location | Maple Grove, MN |
| Product Type | Devices |
| Quantity | 3500 units |
Product Description
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Reason for Recall
Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea
Lot / Code Information
lots 27686, 27293, 22446
Other Recalls from Vascular Solutions, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0113-2021 | Class I | Langston Dual Lumen Catheter. | Aug 31, 2020 |
| Z-0110-2021 | Class I | Langston Dual Lumen Catheter | Aug 31, 2020 |
| Z-0111-2021 | Class I | Langston Dual Lumen Catheter. | Aug 31, 2020 |
| Z-0112-2021 | Class I | Langston Dual Lumen Catheter. | Aug 31, 2020 |
| Z-1747-2020 | Class I | Langston Dual Lumen Catheter 6F Model 5540. Fo... | Mar 16, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.