GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The...
FDA Device Recall #Z-1250-2017 — Class II — January 12, 2017
Recall Summary
| Recall Number | Z-1250-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 12, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vascular Solutions, Inc. |
| Location | Maple Grove, MN |
| Product Type | Devices |
| Quantity | 633 |
Product Description
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Reason for Recall
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Distribution Pattern
US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.
Lot / Code Information
Lot Numbers: 581212, 584392, 594115, 597202
Other Recalls from Vascular Solutions, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0112-2021 | Class I | Langston Dual Lumen Catheter. | Aug 31, 2020 |
| 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-1747-2020 | Class I | Langston Dual Lumen Catheter 6F Model 5540. Fo... | Mar 16, 2020 |
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.