BEUDAMED
    FDA Recall Terminated

    LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48

    Recall: Z-0559-05 · Initiated February 7, 2005

    Recall

    Recall Number
    Z-0559-05
    Event Number
    31108
    Firm
    Lemaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2005
    Posted
    February 24, 2005
    Terminated
    July 25, 2005
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48

    Reason

    Product sterility maybe compromised due to defective packaging

    Action

    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.

    Distribution

    AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany

    Quantity

    411 units