BEUDAMED
    FDA Recall Terminated

    Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550

    Recall: Z-0103-2008 · Initiated September 11, 2007

    Recall

    Recall Number
    Z-0103-2008
    Event Number
    44901
    Firm
    Boston Scientific
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 11, 2007
    Posted
    October 27, 2007
    Terminated
    February 24, 2008
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550

    Reason

    Missing holes: Catheters are missing the catheter's side holes.

    Action

    A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.

    Distribution

    Worldwide: NY, PA, and Japan

    Quantity

    6