BEUDAMED
    FDA Recall Open, Classified

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    Recall: Z-3091-2024 · Initiated May 31, 2024

    Recall

    Recall Number
    Z-3091-2024
    Event Number
    94974
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BTL
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    May 31, 2024
    Posted
    September 20, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    Reason

    Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

    Action

    Smiths Medical issued an URGENT MEDIC AL DEVICE CORRECTION notice to its consignees on05/31/2024 via letter. The notice explained the issue, potential risk, and requested the following: "Perform an inspection to determine if your devices are affected, per the instructions below: a. First perform a visual inspection to determine if the outlet connector is disconnected. b. Second evaluate the connector physically to determine if the outlet connector is loose or moves when placing a patient circuit on the connector or when removing it. c. If outlet connector remains tight after physical inspection, you can continue use of the device with heightened awareness and following all pre-use checks as per the user manual. d. If the outlet connector moves or feels loose, the device must be removed from use and repaired by Smiths Medical. Report the event to Global Complaint Management at [email protected]. Every use thereafter of every device, pre-use checks must be completed as described in the user manual and extra caution must be taken in inspecting the outlet connector prior to use and placing the patient circuit on the connector and during removal. Share this recall notification with all potential users of the devices to ensure they are aware of this recall and proposed mitigations." Those distributing the affected devices were directed to notify those to whom the devices were distributed. Device Correction Inquiries: contact - https://icumed.custhelp.com/app/marketaction

    Distribution

    Worldwide distribution.

    Quantity

    3182 units