BEUDAMED
    FDA Recall Terminated

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.

    Recall: Z-2544-2018 · Initiated May 10, 2018

    Recall

    Recall Number
    Z-2544-2018
    Event Number
    80380
    Firm
    Life Technologies, Corp.
    FEI Number
    1317268
    Product Code
    NDS
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 10, 2018
    Posted
    July 25, 2018
    Terminated
    May 5, 2020
    Address
    3175 Staley Rd, Grand Island, NY, 14072-2028

    Description

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. 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.

    Action

    Urgent Medical Device Recall Notification letters dated 6/28/18 were distributed to customers to notify them of the recall of GIBCO CTS AIM V Serum-Free Media (SFM); Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate; Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose; and Gibco RPMI 1640 Medium. The letters instructed customers to do the following: For the above mentioned lots of product, please complete an inspection of the seal integrity of your inventory. There should not be visual evidence of media within the space between the media bag itself and the dust cover. If you are using product that was manufactured between the dates noted above and you have confirmed media between the media bag and dust cover, we ask that you dispose of these bags per local and state requirements and complete the attached Customer Response Form. As noted above, for bags that do not have any visible media beyond the seal, we have confirmed through sterility testing that these units meet sterility specifications and are acceptable for use. Please inform all affected users within your organization of this notification. If you have used this product in manufacturing, you must notify impacted customers and impacted facilities of this notice and our concern for the potential of fill tube seal integrity loss. Please complete the following Customer Response Sheet if you have product that was manufactured between September 2017 and December 2017 and you have confirmed visual evidence of media between the media bag and dust cover. We will work with you to ensure that you receive credit for the discarded material. North American customers: Please complete the following Customer Response Sheet if you have confirmed visual evidence of at the bag-port or media between the media bag and dust cover in your material. Email a scanned copy of the response sheet along with this letter to [email protected]. If you have any questions, please ca

    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

    45