BEUDAMED
    FDA Enforcement Class II Ongoing

    FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510

    Recall: Z-1747-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1747-2022
    Event ID
    90808
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carwild Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 21, 2022
    Initiation Date
    August 2, 2022
    Classification Date
    September 15, 2022
    Address
    3 State Pier Rd, New London, CT, 06320-5817, United States

    Description

    FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510

    Reason

    Sterility with new cotton source not validated

    Code Info

    UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428

    Distribution

    US Nationwide

    Quantity

    90 CASES (4500 EACHES)