BEUDAMED
    FDA Recall Terminated

    In-Line ventilator adaptor

    Recall: Z-1138-2022 · Initiated April 26, 2022

    Recall

    Recall Number
    Z-1138-2022
    Event Number
    90061
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    NHJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 26, 2022
    Posted
    May 30, 2022
    Terminated
    August 20, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    In-Line ventilator adaptor

    Reason

    There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

    Action

    The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.

    Distribution

    US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

    Quantity

    259 units