Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is ...
FDA Device Recall #Z-1779-2020 — Class II — March 17, 2020
Recall Summary
| Recall Number | Z-1779-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Degania Medical Devices Pvt. Ltd. |
| Location | Gurgaon, N/A |
| Product Type | Devices |
| Quantity | 2500 |
Product Description
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason for Recall
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Lot / Code Information
Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
Other Recalls from Degania Medical Devices Pvt. Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1780-2020 | Class II | Temperature Sensing 100% Silicone Foley Cathete... | Mar 17, 2020 |
| Z-1781-2020 | Class II | Temperature Sensing 100% Silicone Foley Cathete... | Mar 17, 2020 |
| Z-1785-2020 | Class II | Temperature Sensing 100% Silicone Foley Cathete... | Mar 17, 2020 |
| Z-1782-2020 | Class II | Temperature Sensing 100% Silicone Foley Cathete... | Mar 17, 2020 |
| Z-1787-2020 | Class II | Temperature Sensing 100% Silicone Foley Cathete... | Mar 17, 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.