BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1074-2017 · Initiated November 23, 2016

    Recall

    Recall Number
    Z-1074-2017
    Event Number
    76132
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    November 23, 2016
    Terminated
    July 19, 2019
    Address
    1 Medline Pl, Mundelein, IL, 60060-4485

    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)..

    Action

    Medline Industries sent an Immediate Action letter dated November 23, 2016, to all affected customers with response forms to their customers. Customers were instructed to destroy the affected Unna Boot Bandages. Affected lots of product remaining at the firm's distribution centers have been placed on hold and quarantined pending destruction. All affected product will be destroyed. For further questions, please call (847) 643-3245.

    Distribution

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

    Quantity

    117,059 units