BEUDAMED
    FDA Recall Terminated

    Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.

    Recall: Z-0432-06 · Initiated May 24, 2004

    Recall

    Recall Number
    Z-0432-06
    Event Number
    32922
    Firm
    Boston Scientific Scimed
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2004
    Posted
    January 24, 2006
    Terminated
    January 23, 2007
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.

    Reason

    Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.

    Action

    A Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product.

    Distribution

    Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom

    Quantity

    10 devices