BEUDAMED
    FDA Enforcement Class II Ongoing

    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

    Recall: Z-1314-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1314-2023
    Event ID
    91557
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fujifilm Irvine Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    January 16, 2023
    Classification Date
    March 30, 2023
    Address
    2511 Daimler St, N/A, Santa Ana, CA, 92705-5533, United States

    Description

    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

    Reason

    Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

    Code Info

    UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001

    Distribution

    U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingdom

    Quantity

    15,131 bottles