BEUDAMED
    FDA Recall 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 · Initiated October 4, 2016

    Recall

    Recall Number
    Z-0926-2017
    Event Number
    75348
    Firm
    Nurse Assist, Inc
    FEI Number
    3002695476
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 4, 2016
    Posted
    January 3, 2017
    Terminated
    August 16, 2017
    Address
    4409 Haltom Rd, Haltom City, TX, 76117-1207

    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.

    Action

    Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email [email protected]. For questions regarding this recall call 817-231-1300.

    Distribution

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

    Quantity

    386,175 syringes