BEUDAMED
    FDA Recall Terminated

    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    Recall: Z-1405-2019 · Initiated April 17, 2019

    Recall

    Recall Number
    Z-1405-2019
    Event Number
    82683
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 17, 2019
    Terminated
    July 10, 2020
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    Reason

    Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.

    Action

    Thermo Fisher Scientific/ Remel notified consignees on about 04/17/2019 via " URGENT MEDICAL DEVICE FIELD ACTION RECALL" letter. Instructions included to locate all affected in inventory, destroy any affected product identified, contact Customer Services or local distributor to arrange for replacements, notify all customers if product was further distributed, and complete and return the Field Action Response form. Customers were also instructed that the requirement for review of reported test results using product beyond the updated expiry date should be determined by the appropriate technical expert at each customer location. Thermo Fisher Scientific/Remel expanded the recall and notified consignees on about 05/08/2019 via "URGENT MEDICAL DEVICE FIELD ACTION RECALL AMENDED NOTICE: ADDITIONAL IMPACTED LOTS" letter. The letter contained the same instructions as the initial letter, but the updated letter provided the additional impacted lots and requested that consignees respond again confirming receipt and understanding of the expansion. Questions or concerns can be directed to Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

    Distribution

    Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.

    Quantity

    248 units