BEUDAMED
    FDA Enforcement Class II Terminated

    BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

    Recall: Z-1710-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1710-2019
    Event ID
    82330
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 12, 2019
    Initiation Date
    March 1, 2019
    Classification Date
    June 3, 2019
    Termination Date
    May 21, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

    Reason

    Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

    Code Info

    Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362

    Distribution

    US distribution to one distributor in VA.

    Quantity

    6,720 units