BEUDAMED
    FDA Enforcement Class II Terminated

    Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds

    Recall: Z-1074-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1074-2017
    Event ID
    76132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    November 23, 2016
    Classification Date
    January 23, 2017
    Termination Date
    July 19, 2019
    Address
    1 Medline Pl, N/A, Mundelein, IL, 60060-4485, United States

    Description

    Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds

    Reason

    Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..

    Code Info

    Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

    Quantity

    117,059 units