BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/m...
FDA Device Recall #Z-0174-2023 — Class II — October 12, 2022
Recall Summary
| Recall Number | Z-0174-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 12, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson Infusion Therapy Systems Inc. |
| Location | Sandy, UT |
| Product Type | Devices |
| Quantity | 56,080 units |
Product Description
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Reason for Recall
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Distribution Pattern
U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A
Lot / Code Information
Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
Other Recalls from Becton Dickinson Infusion Therapy Sys...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0400-2024 | Class II | BD Insyte Autoguard BC Shielded IV Catheter wit... | Oct 4, 2023 |
| Z-0025-2024 | Class II | REF: 386862, BD Cathena Safety IV catheter with... | Aug 29, 2023 |
| Z-0306-2022 | Class II | BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml... | Sep 8, 2021 |
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.