BEUDAMED
    FDA Enforcement Class I Ongoing

    McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    Recall: Z-2458-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2458-2019
    Event ID
    83500
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Allergan PLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    September 18, 2019
    Initiation Date
    July 24, 2019
    Classification Date
    September 11, 2019
    Address
    2525 Dupont Dr, Irvine, CA, 92612-1531, United States

    Description

    McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    Reason

    The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

    Code Info

    ALL LOTS;

    Distribution

    Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (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, WA, WI, WV, WY). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.

    Quantity

    4,026,287 Breast Implants and Tissue Expanders Combined in total