BEUDAMED
    FDA Enforcement Class II Ongoing

    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

    Recall: Z-1010-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1010-2024
    Event ID
    93744
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 18, 2023
    Classification Date
    February 7, 2024
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619, United States

    Description

    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

    Reason

    Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

    Code Info

    UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

    Distribution

    United States (MD, LA & UT), Austria, Canada and Spain.

    Quantity

    7 eaches