Events

Recall of Device Recall Guardian walker wheel kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by A & E Industries, Ltd..

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
    35786
  • Event Risk Class
    Class 2
  • Event Number
    Z-1421-06
  • Event Initiated Date
    2006-06-30
  • Event Date Posted
    2006-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46878
  • 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
    walker wheel kits - Product Code ITJ
  • Reason
    Walker wheel hubs may fracture, causing walker to collapse to one side.
  • Action
    Consignees were notified by letter on 06/30/2006.

Device

Device Recall Guardian walker wheel kits
  • Model / Serial
    Model numbers 07722-8, 07722G, 07722-5, 07722-8B, 07725. Lot numbers 0603, 0604, 0605.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA and countries of Bangladesh, Chile, Japan, and Mexico
  • Product Description
    Guardian 5 inch Walker Wheel Kits, Model Numbers: 07722-8, 07722G, 07722-5, 07722-8B, 07725. Made in China by A&E; Machinery Industry Co., Ltd.
  • Manufacturer
    A & E Industries, Ltd.

Manufacturer

A & E Industries, Ltd.
  • Manufacturer Address
    A & E Industries, Ltd., Shenghui, South Road, Nantou Town,, Zhong Shan City, Guangdong China
  • Source
    USFDA