BEUDAMED
    FDA Recall Open, Classified

    Welch Allyn Connex Spot Monitor

    Recall: Z-2581-2023 · Initiated August 10, 2023

    Recall

    Recall Number
    Z-2581-2023
    Event Number
    92874
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    MWI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 10, 2023
    Posted
    September 12, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Welch Allyn Connex Spot Monitor

    Reason

    Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

    Action

    The consignee recall notification was sent out via email 08/10/2023. The letter instructs the consignee to immediately locate, isolate, and cease all use of the affected product, contact Baxter Customer Service and Technical Support to arrange for return and replacement of the impacted units, acknowledge receipt by responding on the customer portal, and notify other affected customers of the consignee. Affected product will be removed from the field and customers will receive replacement units of the Connex Spot Monitor. Impacted product will be returned to Baxter and will be destroyed per the Return Material Authorization process.

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    2 units