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U.S. Department of Health and Human Services

Class 2 Device Recall Access Point Quad Cane

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  Class 2 Device Recall Access Point Quad Cane see related information
Date Initiated by Firm March 10, 2006
Date Posted November 22, 2006
Recall Status1 Terminated 3 on April 24, 2008
Recall Number Z-0203-2007
Recall Event ID 35920
Product Classification cane - Product Code IPS
Product Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome), Product Code CN11050, packaged 10/case. The responsible firm on the label is Access Point Medical, St. Louis, MO.
Code Information All canes bearing the model number.
Recalling Firm/
Manufacturer		 Access Point Medical LLC
Three City Place Drive
Suite 750
St. Louis MO 63141
For Additional Information Contact Richard A. Davis
314-255-2702
Manufacturer Reason
for Recall		 The canes were made of unacceptable materials and could break
FDA Determined
Cause 2		 Other
Action The firm began making telephone calls and issuing recall letters dated 3/9/06 via UPS on 3/10/06. The telephone call explained the reason for recall and notified the customer they would be receiving a letter requesting return of the canes. The letter additionally notified the customer the recall was to be affected to the retail level. A customer response form was enclosed. The firm issued a second recall letter dated 12/22/06 via registered mail on 12/26/06 explaining the reason for recall, pointing out the hazard involved with the use of the recalled canes, and requesting they cease sales of the product. The letter requested they notify their customers of the recall and to post the enclosed recall placard where it can be seen by returning customers. Recall instructions were enclosed outlining step-by-step instructions for their customer to follow, including destroying the canes on site. A Customer Response Form was also enclosed. The firm issued a third letter dated 1/11/07 via regular mail which included a corrected placard because the product code numbers were incorrect in the placard included with the letter dated 12/22/06. The customers were instructed to discard the previous placard.
Quantity in Commerce 47/10-cane cases
Distribution Nationwide.
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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