Medical device recalls Moderate risk

Unna-Z recalled over mold contamination

Recall date
November 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Medline Industries Inc recalls Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Recall number
Z-1074-2017
FDA classification
Class II
Brand / firm
Medline Industries Inc
Sold / distributed
Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

Why it was recalled

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)..

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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