Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
FDA Device Recall #Z-2740-2018 — Class II — June 18, 2018
Recall Summary
| Recall Number | Z-2740-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 18, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beaver Visitec |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 440 |
Product Description
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Reason for Recall
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Distribution Pattern
Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
Lot / Code Information
Lot Number 6001700
Other Recalls from Beaver Visitec
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1111-2019 | Class II | Beaver Xstar Slit Knife 2.4 mm, 45degree Double... | Mar 12, 2019 |
| Z-1088-2019 | Class III | Micro Knife 5.0mm 30¿, Part Number 0001522 ... | Feb 19, 2019 |
| Z-1066-2019 | Class II | BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm ... | Nov 30, 2018 |
| Z-3045-2018 | Class II | Beaver Accu-Temp High Temperature Cautery, 2 in... | Jul 19, 2018 |
| Z-2342-2018 | Class II | Safety Sideport Knife 1.0mm 45¿, REF 378210 ... | May 14, 2018 |
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.