BEUDAMED
    FDA Recall Open, Classified

    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

    Recall: Z-1930-2021 · Initiated March 16, 2021

    Recall

    Recall Number
    Z-1930-2021
    Event Number
    87787
    Firm
    Cardinal Health Inc.
    FEI Number
    3004008697
    Product Code
    PZE
    Status
    Open, Classified
    Root Cause
    Environmental control
    Initiated
    March 16, 2021
    Address
    7000 Cardinal Pl, Dublin, OH, 43017-1091

    Description

    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

    Reason

    Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

    Action

    On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2. SEGREGATE and QUARANTINE all affected product. 3. RETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to [email protected], even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)

    Distribution

    US Nationwide distribution in the states of FL, GA, SC.

    Quantity

    8,959 kits