BEUDAMED
    FDA Enforcement Class II Terminated

    HEMASHIELD Knitted Double Velour Cardiovascular Fabric

    Recall: Z-1172-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1172-2018
    Event ID
    79536
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GETINGE US SALES LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    January 3, 2018
    Classification Date
    March 23, 2018
    Termination Date
    July 3, 2018
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    HEMASHIELD Knitted Double Velour Cardiovascular Fabric

    Reason

    A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

    Code Info

    UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229

    Distribution

    FL

    Quantity

    1