BEUDAMED
    FDA Enforcement Class I Terminated

    Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush

    Recall: Z-0926-2017 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0926-2017
    Event ID
    75348
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nurse Assist, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 11, 2017
    Initiation Date
    October 4, 2016
    Classification Date
    January 3, 2017
    Termination Date
    August 16, 2017
    Address
    4409 Haltom Rd, N/A, Haltom City, TX, 76117-1207, United States

    Description

    Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush

    Reason

    Potential contamination with B. cepacia.

    Code Info

    Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)

    Distribution

    Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

    Quantity

    386,175 syringes