BEUDAMED
    FDA Recall Terminated

    Howell D.A.S.H. II Access System, Wire Guided Sphincterotome

    Recall: Z-0301-04 · Initiated December 17, 2003

    Recall

    Recall Number
    Z-0301-04
    Event Number
    27958
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 17, 2003
    Posted
    January 7, 2004
    Terminated
    April 16, 2004
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Howell D.A.S.H. II Access System, Wire Guided Sphincterotome

    Reason

    Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.

    Action

    Consignees were notified by letter sent via Certified Mail on December 17, 2003.

    Distribution

    Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.

    Quantity

    18 units