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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/
Manufacturer		 A & E Industries, Ltd.
Shenghui, South Road, Nantou Town,
Zhong Shan City
Guangdong China
For Additional Information Contact Kevin Walls
720-962-5412
Manufacturer Reason
for Recall		 Walker wheel hubs may fracture, causing walker to collapse to one side.
FDA Determined
Cause 2		 Other
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.
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