FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use...
FDA Device Recall #Z-0076-2018 — Class II — September 28, 2017
Recall Summary
| Recall Number | Z-0076-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 28, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sorin Group USA, Inc. |
| Location | Arvada, CO |
| Product Type | Devices |
| Quantity | 40 units |
Product Description
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
Reason for Recall
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to France and Spain
Lot / Code Information
Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185
Other Recalls from Sorin Group USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2776-2017 | Class II | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz | Jun 30, 2017 |
| Z-2771-2017 | Class II | STOCKERT Heater-Cooler System 3T, 230 V | Jun 30, 2017 |
| Z-2772-2017 | Class II | STOCKERT Heater-Cooler System 3T, 240V/60 Hz | Jun 30, 2017 |
| Z-2775-2017 | Class II | STOCKERT Heater-Cooler System 3T, 120V/60 Hz | Jun 30, 2017 |
| Z-2773-2017 | Class II | STOCKERT Heater-Cooler System 3T, 208V/60 Hz | Jun 30, 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.