BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is int...
FDA Device Recall #Z-1066-2019 — Class II — November 30, 2018
Recall Summary
| Recall Number | Z-1066-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 30, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beaver Visitec |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 3430 units |
Product Description
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
Reason for Recall
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.
Lot / Code Information
Lots 60047S4, 60060S9, 600623S
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-3045-2018 | Class II | Beaver Accu-Temp High Temperature Cautery, 2 in... | Jul 19, 2018 |
| Z-2740-2018 | Class II | Slit Knife 2.6mm 45degree Bevel Up, Model Numbe... | Jun 18, 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.