BEUDAMED
    FDA Recall Terminated

    DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

    Recall: Z-0198-2009 · Initiated October 1, 2008

    Recall

    Recall Number
    Z-0198-2009
    Event Number
    49553
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 1, 2008
    Posted
    November 7, 2008
    Terminated
    December 2, 2009
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

    Reason

    Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.

    Action

    The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.

    Distribution

    LA & KY

    Quantity

    30 kits