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U.S. Department of Health and Human Services

Class 2 Device Recall SHOPKO Waterproof Adhesive Pads Antibacterial

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 Class 2 Recall
SHOPKO Waterproof Adhesive Pads Antibacterial
see related information
Date Posted October 01, 2013
Recall Status1 Open
Recall Number Z-0004-2014
Recall Event ID 66357
Product Classification Tape And Bandage,Adhesive(With Disinfectant) - Product Code MXE
Product SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Code Information UPC Code #: 400129133311 Lot numbers: 330543 and 341383
Recalling Firm/
Manufacturer
ASO, LLC
300 Sarasota Center Blvd
Sarasota, Florida 34240-9381
Manufacturer Reason
for Recall
No antibacterial bandages were packed in boxes labeled as antibacterial.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action A letter was sent via e-mail and mail to the only customer on August 23, 2013 that a recall of two lots was in progress and to examine their inventory and stop distribution of the product. Product was to be either place in quarantine or destroyed. A credit for all returned product or by returned completed certificate of destruction.
Quantity in Commerce 37 cases (72 retail boxes in each case)
Distribution Distributed in the states of ID, WI, IN, and NE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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