Events

Recall of Device Recall Sit/stand Rolling Walker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Central Purchasing LLC DBA Harbor Freight Tools.

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
    67876
  • Event Risk Class
    Class 2
  • Event Number
    Z-1451-2014
  • Event Initiated Date
    2014-03-27
  • Event Date Posted
    2014-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126545
  • 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, mechanical - Product Code ITJ
  • Reason
    Harbor freight tools intiaited a recall of sit/stand rolling walker (sku/item number 66838, sold june 2009 to march 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.
  • Action
    Recall communication to web site customers who purchased the product, notifying them of recall and availability of full refund for product. Store posting notifying retail customers of the recall and availability of full refund for product (with a similar posting provided on the HFT web site). Consumers are informed of the recall, product info. with photo, item number, reason for recall, hazard, instructed to stop using these walkers immediately, and contact information provided telephone number, and e-mail address. Consumer letters also provided with a Merchandise Return Label. On 04/02/14, an updated consumer letter issued.

Device

Device Recall Sit/stand Rolling Walker
  • Model / Serial
    SKU/Item Number 66838, Sold June 2009 to March 2014.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
  • Manufacturer
    Central Purchasing LLC DBA Harbor Freight Tools

Manufacturer

Central Purchasing LLC DBA Harbor Freight Tools
  • Manufacturer Address
    Central Purchasing LLC DBA Harbor Freight Tools, 26541 Agoura Rd, Calabasas CA 91302-2093
  • Manufacturer Parent Company (2017)
    Central Purchasing Llc
  • Source
    USFDA