BEUDAMED
    FDA Recall 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 · Initiated July 6, 2020

    Recall

    Recall Number
    Z-2804-2020
    Event Number
    86044
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    NFK
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    July 6, 2020
    Terminated
    November 5, 2021
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    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.

    Action

    Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.

    Distribution

    World wide distribution