BEUDAMED
    FDA Recall Open, Classified

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    Recall: Z-0821-2025 · Initiated December 10, 2024

    Recall

    Recall Number
    Z-0821-2025
    Event Number
    95967
    Firm
    Mercury Enterprises, Inc. dba Mercury Medical
    FEI Number
    1024404
    Product Code
    BTL
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 10, 2024
    Posted
    January 10, 2025
    Address
    11300 49th St N, Clearwater, FL, 33762-4807

    Description

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    Reason

    Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

    Action

    On 12/10/2024, "URGENT: FIELD SAFETY NOTICE" letters were mailed and emailed to medical facilities and distributors who were asked to do the following: Medical Facilities/Distributors: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Contact firm's customer service department at [email protected] (Domestic) and [email protected] (International) to assist you on how to send the affected product back to the firm for product replacement or credit. 3) Please notify all personnel subject to using these devices. 4) Complete and return the response form via email to [email protected] In addition, distributors were asked to do the following: 5) Provide a copy of this recall notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. If you have any questions regarding this action, contact the firm at 800-237-6418/727-573-0088, or e-mail at [email protected]

    Distribution

    Worldwide Distribution: US (nationwide) to states of: PA, FL, IN, WI, ME, SC, WY, ID, MT, TX, MI, LA, MS, AR, WV, MD, KY, NJ, WA, CA, GA, MO, MA, NC, NV, TN, VA, OK, ND, MN, AL, HI, UT, NY, AZ, IL, OH, IA, NE, CT, AK, OR and OUS (foreign) to countries of: Hungary, Switzerland, Hong Kong, Spain, Canada, Italy, United Kingdom, United Arab Emirates, Saudi Arabia, France, Netherlands

    Quantity

    37370