BEUDAMED
    FDA Recall Terminated

    AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.

    Recall: Z-0906-04 · Initiated April 21, 2004

    Recall

    Recall Number
    Z-0906-04
    Event Number
    28903
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 21, 2004
    Posted
    July 20, 2004
    Terminated
    June 10, 2004
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.

    Reason

    The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.

    Action

    Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.

    Distribution

    MA, NY, OK

    Quantity

    5 boxes/10 pouches per box