Mercury Medical is recalling Neo-Tee Resuscitators due to a risk of the inline controller malfunctioning, potentially causing a loss of ventilation.

Pubished: October 7, 2024

RT’s Three Key Takeaways:

1. Device Malfunction Risk: Mercury Medical is recalling Neo-Tee Resuscitators due to a potential inline controller malfunction that could lead to a loss of positive pressure, compromising ventilation for newborns and infants.
2. Serious Health Hazards: The FDA has classified the recall as a Class I, the most serious type, with potential risks including injury from lack of oxygen or even death. No injuries or deaths have been reported.
3. Immediate Action Required: Medical facilities and distributors are instructed to stop using and distributing affected products, quarantine them, and return them to Mercury Medical for replacement or credit.

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, according to a medical device recall notice from the US Food and Drug Administration (FDA). 

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 and infants weighing less than 22 pounds.

This recall involves removing certain devices from where they are used or sold. The use of the affected product may cause serious adverse health consequences, including injury from lack of oxygen and death. There have been no reported injuries and no reports of death. The FDA has identified this at a Class I recall, the most serious type. 

Affected Product:

• Product Name: Neo-Tee T-Piece Resuscitator with manometer and controller with pressure relief valve

What to Do

Do not use affected product. On Sept 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 [email protected] 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 [email protected] to assist with returning affected product to Mercury Medical for replacement or credit.

Customers in the United States 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 [email protected].

Photo caption: Neo-Tee Resuscitator

FIle photo