BEUDAMED
    FDA Enforcement Class II Terminated

    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.

    Recall: Z-2804-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2804-2020
    Event ID
    86044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2020
    Initiation Date
    July 6, 2020
    Classification Date
    August 13, 2020
    Termination Date
    November 5, 2021
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.

    Reason

    The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

    Code Info

    Product Code: NRH-15192 Lot #: 13F19H0454

    Distribution

    World wide distribution

    Quantity

    N/A