Mercury Medical Pulls Resuscitators Off Market Over Risk of Inline Controller Detachment

Mercury Medical has advised customers to remove two lots of its Neo-Tee T-Piece resuscitators from where they are used or sold.
 
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’s intended for use with newborns and infants weighing less than 22 lbs.
 
The resuscitators’ recall came about because of a possibility for the inline controller to come apart. This causes a loss of positive pressure, which impacts patient ventilation and stops the the inline controller from being used.
 
Though there have not yet been reports of injuries or death over the issue, the FDA warned that using the affected product can cause injury from lack of oxygen and potential death.
 
In its September 4, 2024 Urgent Field Safety Notice, Mercury Medical advised medical facilities to check their inventory for the affected lots of Neo-Tee T-Piece resuscitators and stop their use and distribution if found. Affected products should be quarantined and Mercury Medical said it will replace or credit returned devices.
 
Distributors were advised to provide the recall notice to customers who have received the recalled product. Each customer must complete the acknowledgement form and return it to the company.