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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian walker wheel kits

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  Class 2 Device Recall Guardian walker wheel kits see related information
Date Initiated by Firm June 30, 2006
Date Posted August 24, 2006
Recall Status1 Terminated 3 on July 20, 2011
Recall Number Z-1421-06
Recall Event ID 35786
Product Classification walker wheel kits - Product Code ITJ
Product 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.
Code Information Model numbers 07722-8, 07722G, 07722-5, 07722-8B, 07725. Lot numbers 0603, 0604, 0605.
Recalling Firm/
A & E Industries, Ltd.
Shenghui, South Road, Nantou Town,
Zhong Shan City
Guangdong China
For Additional Information Contact Kevin Walls
Manufacturer Reason
for Recall
Walker wheel hubs may fracture, causing walker to collapse to one side.
FDA Determined
Cause 2
Action Consignees were notified by letter on 06/30/2006.
Quantity in Commerce 63,153 units.
Distribution Worldwide distribution --- USA and countries of Bangladesh, Chile, Japan, and Mexico
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.