BEUDAMED
    FDA Recall Terminated

    Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

    Recall: Z-1780-2019 · Initiated May 2, 2019

    Recall

    Recall Number
    Z-1780-2019
    Event Number
    82910
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 2, 2019
    Terminated
    August 23, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

    Reason

    The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.

    Action

    Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.

    Distribution

    No distribution in the US. Products were distributed to the following foreign countries: China.

    Quantity

    97