BEUDAMED
    FDA Recall Open, Classified

    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

    Recall: Z-0340-2025 · Initiated October 9, 2024

    Recall

    Recall Number
    Z-0340-2025
    Event Number
    95499
    Firm
    The Metrix Company
    FEI Number
    1000117446
    Product Code
    KPE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 9, 2024
    Posted
    November 8, 2024
    Address
    4400 Chavenelle Rd, Dubuque, IA, 52002-2655

    Description

    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

    Reason

    A limited number of IV bags have been found to leak during filling.

    Action

    The Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. For questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: [email protected]

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.

    Quantity

    1020 cases of 50 units