BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control F...
FDA Device Recall #Z-0800-2019 — Class II — December 6, 2018
Recall Summary
| Recall Number | Z-0800-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 6, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Medical Division |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 450 units |
Product Description
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Reason for Recall
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Distribution Pattern
US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Lot / Code Information
Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018
Other Recalls from Bard Medical Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0803-2019 | Class II | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Cl... | Dec 13, 2018 |
| Z-2536-2018 | Class II | Arctic Sun Temperature Management System, Model... | Jun 13, 2018 |
| Z-2943-2018 | Class II | Bard Midstream Urine Collector with Rigid Funne... | Mar 21, 2018 |
| Z-1241-2019 | Class II | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: ... | Nov 8, 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.