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U.S. Department of Health and Human Services

Class 2 Device Recall Boot Compression Wrap

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  Class 2 Device Recall Boot Compression Wrap see related information
Date Initiated by Firm August 30, 2018
Create Date October 06, 2018
Recall Status1 Terminated 3 on February 09, 2023
Recall Number Z-0088-2019
Recall Event ID 80972
Product Classification Bandage, liquid, skin protectant - Product Code NEC
Product Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4

Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.
Code Information Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712. 
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES INC
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
FDA Determined
Cause 2		 Environmental control
Action On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm.
Quantity in Commerce 113,302 units
Distribution United States, Taiwan, Chile
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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