Mary Wilson
Well-known member
Content current as of: 01/31/2025
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
On December 5, 2024, Mercury Medical sent all affected customers an Urgent Field Safety Notice recommending the following actions:
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
...
https://www.fda.gov/medical-devices...r-due?utm_medium=email&utm_source=govdelivery
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
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.
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 |
https://www.fda.gov/medical-devices...r-due?utm_medium=email&utm_source=govdelivery