BEUDAMED
    FDA Enforcement Class II Ongoing

    (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).

    Recall: Z-1421-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1421-2023
    Event ID
    91722
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    March 16, 2023
    Classification Date
    April 21, 2023
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).

    Reason

    A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.

    Code Info

    Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.

    Distribution

    Distribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WV, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Canada.

    Quantity

    726 units