BEUDAMED
    FDA Recall Terminated

    Access Point Medical Canes, Quad Cane, Large Base - Gold, Product Code CN11070B, and Large Base - Chrome, Product Code CN11070C, both packaged 6/case. The responsible firm on the label is Access Point Medical, St. Louis, MO.

    Recall: Z-0205-2007 · Initiated March 10, 2006

    Recall

    Recall Number
    Z-0205-2007
    Event Number
    35920
    Firm
    Access Point Medical LLC Three City Place Drive Suite 750 St. Louis MO 63141
    FEI Number
    3005009085
    Product Code
    IPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2006
    Posted
    November 22, 2006
    Terminated
    April 24, 2008

    Description

    Access Point Medical Canes, Quad Cane, Large Base - Gold, Product Code CN11070B, and Large Base - Chrome, Product Code CN11070C, both packaged 6/case. The responsible firm on the label is Access Point Medical, St. Louis, MO.

    Reason

    The canes were made of unacceptable materials and could break

    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.

    Distribution

    Nationwide.

    Quantity

    63/6-cane cases