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U.S. Department of Health and Human Services

Class 2 Device Recall Sit/stand Rolling Walker

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  Class 2 Device Recall Sit/stand Rolling Walker see related information
Date Initiated by Firm March 27, 2014
Date Posted April 10, 2014
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-1451-2014
Recall Event ID 67876
Product Classification Walker, mechanical - Product Code ITJ
Product Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
Code Information SKU/Item Number 66838, Sold June 2009 to March 2014.
Recalling Firm/
Central Purchasing LLC DBA Harbor Freight Tools
26541 Agoura Rd
Calabasas CA 91302-2093
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
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.
Quantity in Commerce 43,621
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

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.