BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal CATARACT PACK CSM, REF 89-6863

    Recall: Z-0580-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0580-2023
    Event ID
    91134
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 21, 2022
    Initiation Date
    November 3, 2022
    Classification Date
    December 15, 2022
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal CATARACT PACK CSM, REF 89-6863

    Reason

    DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

    Code Info

    Lot Numbers: Lot 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***

    Distribution

    US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

    Quantity

    1220 kits