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U.S. Department of Health and Human Services

Class 2 Device Recall UnnaZ, Unna Boot with Zinc and Calamine

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  Class 2 Device Recall UnnaZ, Unna Boot with Zinc and Calamine see related information
Date Initiated by Firm November 23, 2016
Create Date January 23, 2017
Recall Status1 Terminated 3 on July 19, 2019
Recall Number Z-1074-2017
Recall Event ID 76132
Product Classification Bandage, elastic - Product Code FQM
Product Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Code Information Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599 
Recalling Firm/
Manufacturer
Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4485
For Additional Information Contact Kassandra Cotner
847-643-3245
Manufacturer 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)..
FDA Determined
Cause 2
Environmental control
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.
Quantity in Commerce 117,059 units
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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