BD Nexiva recallZ-0174-2023 · Becton Dickinson Infusion Therapy Systems Inc. · initiated Oct 12, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson Infusion Therapy Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Storage
What the company is doing
On 10/12/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx and email, to customers informing them that Becton, Dickinson (BD) confirmed that during withdrawal of the Nexiva product, the tip shield may prematurely separate from the catheter adapter and prevent the needle tip from being safely shielded. As a result, the clinicians could potentially experience a contaminated needlestick injury after withdrawal of the needle. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all unused product subject to the recall following their institution s process for destruction. 2. For indwelling catheters, no further action is needed. As indicated, these catheters can remain in place and continue to be used per the Instructions for Use. 3. If the affected product was previously used in patient care, no further action is needed. 4. Share this recall notification with all users within their facility network of the product to ensure they are also aware of this recall. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not they have any of the impacted material so that BD may acknowledge their receipt of this notification per FDA requirements and subsequently process your product replacement. For questions - contact North America Regional Complaint Center at Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected]
Recall details
- Recall number
- Z-0174-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 12, 2022
- Posted by the FDA
- Nov 3, 2022
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Quantity
- 56,080 units
- Product code
- FOZ
- FDA submissions
- K183399
- Distribution
- 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
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)
Code information (models, lots, serial numbers)
Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Nexiva 383516Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall294 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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