Date Initiated by Firm |
August 21, 2013 |
Date Posted |
October 01, 2013 |
Recall Status1 |
Terminated 3 on August 04, 2014 |
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 FL 34240-9381
|
For Additional Information Contact |
941-379-0300 Ext. 1156
|
Manufacturer Reason for Recall |
No antibacterial bandages were packed in boxes labeled as antibacterial.
|
FDA Determined Cause 2 |
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. |
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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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