BEUDAMED
    FDA Enforcement Class II Terminated

    U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.

    Recall: Z-0355-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0355-2016
    Event ID
    72596
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Procedure Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 9, 2015
    Initiation Date
    October 27, 2015
    Classification Date
    December 1, 2015
    Termination Date
    April 1, 2016
    Address
    1801 W Fourth Plain Blvd, Vancouver, WA, 98660-1310, United States

    Description

    U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.

    Reason

    The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

    Code Info

    Lot 9184-A

    Distribution

    Distributed in the states of MT and NY.

    Quantity

    1100 pieces