BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 18, 2023

    Recall

    Recall Number
    Z-1010-2024
    Event Number
    93744
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    KRA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 18, 2023
    Posted
    February 7, 2024
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    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.

    Action

    An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.

    Distribution

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

    Quantity

    7 eaches