BEUDAMED
    FDA Recall Open, Classified

    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)

    Recall: Z-0174-2023 · Initiated October 12, 2022

    Recall

    Recall Number
    Z-0174-2023
    Event Number
    90972
    Firm
    Becton Dickinson Infusion Therapy Systems Inc.
    FEI Number
    1710034
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Storage
    Initiated
    October 12, 2022
    Posted
    November 3, 2022
    Address
    9450 S State St, Sandy, UT, 84070-3213

    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

    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).

    Action

    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]

    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

    Quantity

    56,080 units