BEUDAMED
    FDA Recall Open, Classified

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    Recall: Z-1926-2019 · Initiated May 31, 2019

    Recall

    Recall Number
    Z-1926-2019
    Event Number
    82999
    Firm
    Infinium Medical, Inc
    FEI Number
    3007513035
    Product Code
    MWI
    Status
    Open, Classified
    Root Cause
    Labeling False and Misleading
    Initiated
    May 31, 2019
    Address
    12151 62nd St, Ste 5, Largo, FL, 33773-3702

    Description

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    Reason

    The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

    Action

    Infinium Medical, Inc. notified customers on about 05/31/2019 via "URGENT: MEDICAL DEVICE RECALL" letter sent through email and certified letter. Instructions included to remove all temperature modules from the CLEO & Tranquility VS Patient Monitors and destroyed. They were also requested to complete and return the Medical Device Recall Return Response Form to [email protected]. Once the response form is received, a new IFU and standalone temperature monitor will be provided. Questions and comments can be sent to Mr. George Anello during regular business hours (8:00 AM - 04:30 PM EST) at QARAinfiniummedical.com or by phone at l-866-918-8434 ext. 109.

    Distribution

    Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.

    Quantity

    95 devices