BEUDAMED
    FDA Enforcement Class II Terminated

    PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

    Recall: Z-2499-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2499-2020
    Event ID
    85847
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2020
    Initiation Date
    June 11, 2020
    Classification Date
    July 4, 2020
    Termination Date
    January 25, 2021
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

    Reason

    Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

    Code Info

    Lot 3921849.

    Distribution

    Domestic Distribution: AR, CT, MS,TN,TX

    Quantity

    46 kits