BEUDAMED
    FDA Recall Open, Classified

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    Recall: Z-0004-2025 · Initiated August 30, 2024

    Recall

    Recall Number
    Z-0004-2025
    Event Number
    95303
    Firm
    Mercury Enterprises, Inc. dba Mercury Medical
    FEI Number
    1024404
    Product Code
    BTL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 30, 2024
    Posted
    October 2, 2024
    Address
    11300 49th St N, Clearwater, FL, 33762-4807

    Description

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    Reason

    Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

    Action

    Mercury Medical notified customers on 09/04/2024 via letter. Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form. Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.

    Distribution

    US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

    Quantity

    1,300 units