bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled,...
FDA Device Recall #Z-0500-2018 — Class II — November 3, 2017
Recall Summary
| Recall Number | Z-0500-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 3, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beaver-Visitec International Inc. |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 45, 680 units |
Product Description
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Reason for Recall
The protective shield was retracted, and the blade was exposed.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Lot / Code Information
(a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442
Other Recalls from Beaver-Visitec International Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1801-2018 | Class II | Wet-Field Hemostatic Eraser Bipolar 25G, fine t... | Feb 26, 2018 |
| Z-1539-2018 | Class II | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP... | Feb 26, 2018 |
| Z-0502-2018 | Class II | bvi Beaver Xstar Safety Slit Knife: (a) REF ... | Nov 3, 2017 |
| Z-0503-2018 | Class II | bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Be... | Nov 3, 2017 |
| Z-0501-2018 | Class II | bvi Beaver Safety Sideport Knife: (a) 1.0mm, 4... | Nov 3, 2017 |
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.