BEUDAMED
    FDA Enforcement Class II Terminated

    CTSTM Essential 8 Medium

    Recall: Z-0275-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0275-2020
    Event ID
    83301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    June 11, 2019
    Classification Date
    November 6, 2019
    Termination Date
    June 4, 2020
    Address
    3175 Staley Rd, N/A, Grand Island, NY, 14072-2028, United States

    Description

    CTSTM Essential 8 Medium

    Reason

    Component was not tested by the supplier for adventitious agents

    Code Info

    SKU: A2656001 Lot: 1955886 (Exp1/30/2019), 1960951 (Exp1/30/2019), 2039735 (Exp1/30/2020)

    Distribution

    StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI. StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Malaysia, Netherlands, Pakistan, Poland, Republic of Korea, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam. CTSTM Essential 8 Medium distributed to the following states in the USA: CA, DC, FL, IA, IL, MA, MD, MN, NC, NY, WA, WI. CTSTM Essential 8 Medium distributed Internationally to the following countries: Australia, Canada, China, France, Germany, India, Japan, Netherlands, Portugal, Republic of Korea, Saudi Arabia, Singapore, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    3693 Kits