Events

Recall of Device Recall SHOPKO Waterproof Adhesive Pads Antibacterial

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ASO, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66357
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-2014
  • Event Initiated Date
    2013-08-21
  • Event Date Posted
    2013-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122141
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tape and bandage,adhesive(with disinfectant) - Product Code MXE
  • Reason
    No antibacterial bandages were packed in boxes labeled as antibacterial.
  • 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.

Device

Device Recall SHOPKO Waterproof Adhesive Pads Antibacterial
  • Model / Serial
    UPC Code #: 400129133311 Lot numbers: 330543 and 341383
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Distributed in the states of ID, WI, IN, and NE.
  • Product Description
    SHOPKO Waterproof Adhesive Pads Antibacterial. || Used for covering minor cuts, scrapes and burns.
  • Manufacturer
    ASO, LLC

Manufacturer

ASO, LLC
  • Manufacturer Address
    ASO, LLC, 300 Sarasota Center Blvd, Sarasota FL 34240-9381
  • Manufacturer Parent Company (2017)
    Aso Corporation
  • Source
    USFDA