Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact 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: Neo-Tee T-Piece Resuscitator with manometer and controller with pressure relief valve
Part Number | Unique Device ID | Description | Lot Number |
---|---|---|---|
1050805 | 10641043508053 30641043508057 |
Neo-Tee Resuscitator | 2417650805 2417750805 |
1050832 | 10641043508329 30641043508323 |
Neo-Tee Resuscitator | 2423550832 2417850832 |
What to Do
- Do not use affected product.
On September 4, 2024, Mercury Medical sent all affected customers an Urgent Field Safety Notice recommending the following actions:
Medical facilities
- Immediately check inventory for product within the scope of this recall.
- Stop use and distribution of affected product.
- Quarantine affected product.
- Contact customer service at uscustomerservice@mercurymed.com to assist with returning affected product to Mercury Medical for replacement or credit.
Distributors
- Provide this recall notice to all customers who have received impacted product.
- Have each customer complete the acknowledgement form and return it.
- Contact customer service at uscustomerservice@mercurymed.com to assist with returning affected product to Mercury Medical for replacement or credit.
Reason for Recall
Mercury Medical is recalling Neo-Tee Resuscitators due to the potential for the inline controller to come apart, causing a loss of positive pressure that will impact effective ventilation of the patient and prevent the inline controller from being used. Customers in the U.S. with questions about this recall should contact their Mercury Medical sales representative or the Mercury Medical team at 800-237-6418/727-573-0088 or regulatoryaffairs@mercurymed.com.
The use of affected product may cause serious adverse health consequences, including injury from lack of oxygen (ischemia) and death.
There have been no reported injuries and no reports of death.
Device Use
The Neo-Tee T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency breathing support through a face mask or a tube in the patient’s airway. It is intended for use with newborns (neonates) and infants weighing less than 22lbs.
Contact Information
Customers in the U.S. with questions about this recall should contact their Mercury Medical sales representative or the Mercury Medical team at 800-237-6418/727-573-0088 or regulatoryaffairs@mercurymed.com.
Additional FDA Resources
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.