BEUDAMED
    FDA Enforcement Class III Ongoing

    FloPatch FP120, REF: FP120-FOT01-005

    Recall: Z-2517-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2517-2025
    Event ID
    97427
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Flosonics Medical (R/A 1929803 ONTARIO CORP.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    August 7, 2025
    Classification Date
    September 4, 2025
    Address
    Fourth Floor, Oneeleven, 325 Front St W, Toronto, N/A, N/A, Canada

    Description

    FloPatch FP120, REF: FP120-FOT01-005

    Reason

    Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

    Code Info

    UDI-DI: 10627987360148. Lot: 03250602

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    9