Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silic...

FDA Device Recall #Z-0403-2017 — Class II — October 13, 2016

Recall Summary

Recall Number Z-0403-2017
Classification Class II — Moderate risk
Date Initiated October 13, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm C.R. Bard, Inc.
Location Covington, GA
Product Type Devices
Quantity 75,089 units

Product Description

Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Reason for Recall

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Distribution Pattern

U.S. Nationwide.

Lot / Code Information

Product Codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407 and 288408.

Other Recalls from C.R. Bard, Inc.

Recall # Classification Product Date
Z-1431-2021 Class II Bard Clean-Cath Intermittent Catheter, 12 Frenc... Jan 11, 2021
Z-1355-2018 Class II Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0... Feb 27, 2018
Z-1357-2018 Class II Bard(R) Premature Infant Feeding tube, ENFit(TM... Feb 27, 2018
Z-1354-2018 Class II Bard(R) Premature Infant Feeding Tube, ENFit(TM... Feb 27, 2018
Z-1356-2018 Class II Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM)... Feb 27, 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.