According to an Oct. 7 notice, Mercury Medical removed 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.
The FDA notice says not to 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 [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.
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 [email protected].
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.
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.
