BEUDAMED
    FDA Recall Terminated

    SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long.

    Recall: Z-1088-04 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-1088-04
    Event Number
    29395
    Firm
    Thomas Medical Products Inc
    FEI Number
    3010665433
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    July 20, 2004
    Terminated
    June 27, 2005
    Address
    65 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long.

    Reason

    Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.

    Action

    The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.

    Distribution

    The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.

    Quantity

    39,605 kits