BEUDAMED
    FDA Recall Terminated

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015

    Recall: Z-1100-03 · Initiated July 1, 2003

    Recall

    Recall Number
    Z-1100-03
    Event Number
    26708
    FEI Number
    3002095335
    Product Code
    GBR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2003
    Posted
    August 12, 2003
    Terminated
    December 28, 2006
    Address
    Boston Scientific Scimed One Scimed Place Maple, Grove, MN, 55311-1566

    Description

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015

    Reason

    Some of the product pouches have holes in the seals.

    Action

    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.

    Distribution

    The recalled products were shipped to hospitals located nationwide in the United States.

    Quantity

    16