BEUDAMED
    FDA Recall Open, Classified

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    Recall: Z-0449-2021 · Initiated July 14, 2020

    Recall

    Recall Number
    Z-0449-2021
    Event Number
    86607
    Firm
    Thomas Scientific
    FEI Number
    2522600
    Product Code
    LIO
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    July 14, 2020
    Address
    1654 High Hill Rd, Swedesboro, NJ, 08085-1780

    Description

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    Reason

    The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

    Action

    On 8/31/20, the firm provided FEMA with the recall letter, which was distributed to all affected users. Users were informed that product manufactured and distributed prior to Enforcement Discretion Approval was to be removed. The firm offered to replace any returned product. To report and receive replacement, customers should complete the included VTM Product Replacement Form and return it to [email protected]. Thomas Scientific will replace any product that has been returned. Please contact [email protected] for any requests for field support.

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    115,800 cs (100 vials/cs)