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Terminated

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

FDA Recall Z-1074-2017 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeFQM
Date Initiated2016-11-23
Date Terminated2019-07-19
Product Quantity117,059 units

Reason for Recall

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)..

Firm 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.

Root Cause

Environmental control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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