BEUDAMED
    FDA Enforcement Class II Terminated

    Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    Recall: Z-1403-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1403-2019
    Event ID
    82683
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    April 17, 2019
    Classification Date
    May 22, 2019
    Termination Date
    July 10, 2020
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Thio Med w/Dex, Hem, Vit K (9ml) 20/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.

    Code Info

    Material Number: R064722; Lot Number (Labeled Expiration Date): 314201 (12/20/2018), 337680 (02/04/2019), 346705 (02/27/2019), 362709 (03/25/2019), 380471 (04/29/2019), 396517 (05/28/2019).

    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

    952 units