BEUDAMED
    FDA Recall Terminated

    enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

    Recall: Z-1386-2019 · Initiated March 13, 2019

    Recall

    Recall Number
    Z-1386-2019
    Event Number
    82393
    Firm
    Vyaire Medical
    FEI Number
    2050001
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 13, 2019
    Posted
    June 26, 2019
    Terminated
    September 22, 2020
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420

    Description

    enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

    Reason

    Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

    Action

    Vyaire Medical notified consignees on about 03/13/2019 via URGENT NOTIFICATION OF RECALL letter. Consignees were instructed to conduct a 100% physical inventory to identify any affected product on hand, destroy all affected product in-stock in accordance with each facility's destruction protocol and if a facility is unable to destroy the product on site, or requires assistance, they were instructed to contact [email protected] or call for assistance. Customers were also instructed to complete and return the Customer Response Form to [email protected], report any adverse reactions or quality problems to Vyaire's Technical Support Department by e-mail [email protected] or telephone at 1-800-231-2466 prompt #1. If customers further distributed the product, they were instructed to forward a copy of the URGENT NOTIFICATION OF RECALL letter and Response Form to all customers and include the contact information to Vyaire for tracking purposes.

    Distribution

    Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam.

    Quantity

    5,782,820 units total