BEUDAMED
    FDA Enforcement Class I Ongoing

    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

    Recall: Z-0208-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0208-2025
    Event ID
    95436
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Percussionaire Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 16, 2024
    Classification Date
    October 30, 2024
    Address
    130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, 83864-8409, United States

    Description

    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

    Reason

    As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.

    Code Info

    Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627

    Distribution

    U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT, CO, LA, VA, CT, SC, NH, NV, NC, NJ, MI, UT, ID, ME, MN, SD, ID, ND, KS, KY, TN, MD, VT, MA, RI, O.U.S.: Canada, Switzerland (all products shipped OUS remained in Sentec AG's (distributor, parent company of Percussionaire) control, were quarantined, and did not leave the warehouse).

    Quantity

    43,830 devices