BD NEXIVA Closed IV Catheter System Dual Port 18GA 1 — Class II medical device recall Z-0384-2019
Terminated recall by Becton Dickinson & Company, reported 2018-11-14, distributed nationwide. One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safet
| Recall number | Z-0384-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2018-08-23 |
| Classified | 2018-11-03 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CO, CR, MX, NZ |
| Quantity | 133,230 units |
| UPC / GTIN / UDI-DI | 30382903835394 |
| Lot numbers | 8087800 |
| Model numbers | 383539 |
Product
BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and minimize exposure to blood during the insertion process. The needle shield is designed to not release from the catheter adapter until the needle tip is protected and cannot be rearmed once activated. The BD Nexiva device is intended for use in the peripheral vascular system to provide access for the administration of fluids, medication, blood and blood products, and for the withdrawal of blood samples. This catheter may be used for any patient population with consideration given to patient size, appropriateness for solutions being infused and duration of therapy.
Reason for recall
One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0384-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.