BEUDAMED
    FDA Enforcement Class II Terminated

    PIVO Blood Collection Device 20G, REF: 202-0005

    Recall: Z-0527-2022 · Reported February 2, 2022

    Enforcement

    Recall Number
    Z-0527-2022
    Event ID
    89185
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Velano Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 2, 2022
    Initiation Date
    November 10, 2021
    Classification Date
    January 25, 2022
    Termination Date
    July 31, 2023
    Address
    221 Pine St # 200, San Francisco, CA, 94104-2705, United States

    Description

    PIVO Blood Collection Device 20G, REF: 202-0005

    Reason

    Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.

    Code Info

    UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02

    Distribution

    US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.

    Quantity

    123,700