BEUDAMED
    FDA Recall Open, Classified

    VACUETTE SAFELINK, REF: 450210

    Recall: Z-0802-2025 · Initiated November 19, 2024

    Recall

    Recall Number
    Z-0802-2025
    Event Number
    95748
    Firm
    Greiner Bio-One GmbH Bad Haller Strase
    FEI Number
    3000974732
    Product Code
    FMI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 19, 2024
    Posted
    January 3, 2025
    Address
    32 Kremsmunster Austria

    Description

    VACUETTE SAFELINK, REF: 450210

    Reason

    The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

    Action

    On 11/19/2024, customers and distributors were mailed and emailed recall notices asking them to do the following: 1) Stop using and isolate affected devices. 2) If the product has been further distributed or transferred to another location, notify those locations of the recall, and advise the name/location in the provided space on the attached Product Disposition Site Confirmation. 3) Complete and return the Product Disposition Site Confirmation form via email to [email protected] If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.

    Distribution

    US Nationwide distribution in the states of IL, PA.

    Quantity

    188,800 pcs