BEUDAMED
    FDA Recall Terminated

    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

    Recall: Z-0709-04 · Initiated February 2, 2004

    Recall

    Recall Number
    Z-0709-04
    Event Number
    28201
    Firm
    Action Products Incorporated
    FEI Number
    1181047
    Product Code
    KNO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2004
    Posted
    July 20, 2004
    Terminated
    September 21, 2004
    Address
    22 N Mulberry St, Hagerstown, MD, 21740-4910

    Description

    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

    Reason

    Wheelchair seat may not properly support the user due to cracks in the plastic seat base.

    Action

    The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.

    Distribution

    Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.

    Quantity

    389 wheelchairs