FDA recalls Mercury Medical T-piece resuscitator due to ventilation control component

The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for emergency use, due to an undersized spring in the ventilation control component.

The FDA has designated this recall as class I, the most serious kind.

The spring is part of a controller that may prevent the device from delivering required pressure levels for ventilation. Affected products may have reduced positive pressure, which could impair breathing support for the patient.

The device is used using a facemask or tube inserted into the airway of a patient who requires ventilation and has been designed with in-line flow control. The recall affects devices used for pediatric patients weighing less than 10 kg.

Customers who own Mercury Medical ventilator products are urged to visit the FDA website to determine whether their device is affected by the recall. If it is found that the device is affected, use and distribution should be ceased immediately.

Potential adverse consequences of using a faulty device may include desaturation, bradycardia, hypoxia, hypercarbia and death. However, no injuries or fatalities have been reported.