BEUDAMED
    FDA Enforcement Class II Ongoing

    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109

    Recall: Z-2162-2024 · Reported June 26, 2024

    Enforcement

    Recall Number
    Z-2162-2024
    Event ID
    94645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2024
    Initiation Date
    May 10, 2024
    Classification Date
    June 20, 2024
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109

    Reason

    The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

    Code Info

    Xstar Safety Slit Knife: UDI-DI: 00886158001652; Lot Number: 6058854; CustomEye Kit # 584562 , lot # 6068524; CustomEye Kit # 584562 , lot # 6068025; CustomEye Kit # 5800109, lot # 6068285

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.

    Quantity

    126 units