BEUDAMED
    FDA Enforcement Class II Ongoing

    Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

    Recall: Z-1694-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1694-2024
    Event ID
    94287
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Allergan Sales, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2024
    Initiation Date
    March 14, 2024
    Classification Date
    April 29, 2024
    Address
    2525 Dupont Dr, Irvine, CA, 92612-1531, United States

    Description

    Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

    Reason

    Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

    Code Info

    UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C

    Distribution

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

    Quantity

    10837