BEUDAMED
    FDA Enforcement Class II Ongoing

    Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

    Recall: Z-2589-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2589-2023
    Event ID
    92796
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    July 7, 2023
    Classification Date
    September 15, 2023
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017, United States

    Description

    Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

    Reason

    Flexible intubation endoscopes sterility assurance can not be confirmed.

    Code Info

    UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.

    Quantity

    218 units