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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 25, 2003
Date Posted May 14, 2003
Recall Status1 Terminated 3 on July 07, 2003
Recall Number Z-0812-03
Recall Event ID 25755
Product Classification Wheelchair, Mechanical - Product Code IOR
Product Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
Code Information LOTS IA702, II327, IK454, IM236
Recalling Firm/
Manufacturer		 Action Products Incorporated
22 N Mulberry Street
Hagerstown MD 21740
For Additional Information Contact Dee Price
800-228-7763
Manufacturer Reason
for Recall		 Stitching in wheelchair seat back is defective and may not support user.
FDA Determined
Cause 2		 Other
Action Firm notified dealers and sales representatives by certified letter on 2/25/03. Dealers were requested to phone the company for replacement options. Sales representatives were advised of the stitching failure via an 'urgent product recall' letter and instructed to immediately cease use and distribution, and further notify customers. Reps were asked to collect all recalled parts WPHS from consignees they have identified and return with response form.
Quantity in Commerce 40 units
Distribution Product was distributed to dealers, independent sales representatives, and distributors around the US and worldwide.
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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