BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.

    Recall: Z-1483-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1483-2022
    Event ID
    90552
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    August 1, 2022
    Address
    710 Medtronic Pkwy Mailstop Ls245, N/A, Minneapolis, MN, 55432-5603, United States

    Description

    Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.

    Reason

    Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

    Code Info

    GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023

    Distribution

    US Nationwide distribution.

    Quantity

    84 units