BEUDAMED
    FDA Enforcement Class II Terminated

    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

    Recall: Z-1561-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1561-2021
    Event ID
    87830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 19, 2021
    Initiation Date
    April 22, 2021
    Classification Date
    May 12, 2021
    Termination Date
    August 8, 2023
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

    Reason

    The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

    Code Info

    Lot #248035, Exp. 2021-04-27

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.

    Quantity

    91/10-test units