BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS

    Recall: Z-1218-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1218-2022
    Event ID
    90125
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    April 21, 2022
    Classification Date
    June 2, 2022
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS

    Reason

    Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

    Code Info

    DI: (01)40888277367389; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.

    Distribution

    US and Panama

    Quantity

    4033 boxes of 25 units