BEUDAMED
    FDA Recall Terminated

    Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.

    Recall: Z-2236-2009 · Initiated June 26, 2009

    Recall

    Recall Number
    Z-2236-2009
    Event Number
    53041
    Firm
    Action Products Incorporated
    FEI Number
    1181047
    Product Code
    JAD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 26, 2009
    Posted
    September 22, 2009
    Terminated
    September 29, 2009
    Address
    954 Sweeney Dr, Hagerstown, MD, 21740-7111

    Description

    Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.

    Reason

    Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.

    Action

    Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.

    Distribution

    Nationwide distribution.

    Quantity

    1 carton