BEUDAMED
    FDA Enforcement Class II Terminated

    Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000

    Recall: Z-1957-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1957-2018
    Event ID
    79890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    April 11, 2018
    Classification Date
    May 30, 2018
    Termination Date
    May 15, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000

    Reason

    Product sterility may be compromised due to unsealed packaging.

    Code Info

    Lot Numbers: 13F17C0232 13F17G0194 13F17H0047 13F17J0083

    Distribution

    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

    Quantity

    416,055 total products