BEUDAMED
    FDA Enforcement Class II Terminated

    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

    Recall: Z-2542-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2542-2018
    Event ID
    80380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 1, 2018
    Initiation Date
    May 10, 2018
    Classification Date
    July 25, 2018
    Termination Date
    May 5, 2020
    Address
    3175 Staley Rd, N/A, Grand Island, NY, 14072-2028, United States

    Description

    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

    Reason

    It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

    Code Info

    Lot: 1921298, 1921302 Updated as of 6/14/19: 1902977 1902981 1904379 1904381 1912383 1915452 1921291 1925754 1921291 1921298 1921302 1925754

    Distribution

    Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.

    Quantity

    Updated as of 6/21/19: 6304 units