Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product

• Product Name: Mercury Medical T-Piece Resuscitator (Neo-Tee)
• Unique Device Identifier (UDI)/Model: See Full List of Affected Devices below
• Lot/Serial Numbers: See Full List of Affected Devices below

What to Do

On December 5, 2024, Mercury Medical sent all affected customers an Urgent Field Safety Notice recommending the following actions:

• Immediately check the inventory for affected product, within the scope of this recall
• Stop use and distribution and immediately quarantine the affected product.
• Provide a copy of this recall notice to all customers who have received impacted product. Notify all personnel subject to using these devices.

Reason for Recall

Mercury Enterprises, Inc. dba Mercury Medical is recalling the Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. This issue could reduce positive pressure, affecting the patient's breathing support.

The use of affected product may cause serious adverse health consequences, including low oxygen levels (desaturation), slow heart rate (bradycardia), lack of oxygen (hypoxia), high carbon dioxide levels (hypercarbia), and death.

There have been no reported injuries or death associated with this issue.

Device Use

The Neo-Tee T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a facemask or a tube inserted into a patient's airway. It is intended for use with pediatric patients weighing less than 10kg (22lbs). The device is designed with in-line flow controller, in the circuit.

Contact Information

Customers in the U.S. with questions about this recall should contact Mercury Medical at 1-727-573-0088. 

Full List of Affected Devices

Part Number	Unique Device ID	Lot Number(s)
1050805	10641043508053, 30641043508057	2421450805, 2423550805, 2423650805, 2426750805
1050808	10641043508084, 30641043508088	2426450808, 2426750808, 2426850808, 2429050808, 2429350808
1050809	10641043508091, 30641043508095	2426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809
1050810	10641043508107, 30641043508101	2426750810, 2429350810, 2429750810, 2429850810, 2430250810
1050811	10641043508114, 30641043508118	2426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811
1050814	10641043508145, 30641043508149	2426450814, 2426750814, 2429050814, 2429750814, 2430250814,
1050832	10641043508329, 30641043508323	2429050832, 242985083
1050839	10641043508398, 30641043508392	2430350839
1050840	10641043508404, 30641043508408	2429050840, 2429750840
1050841	10641043508411, 30641043508415	2429050841
1050842	10641043508428, 30641043508422	2426750842

Additional FDA Resources

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.