FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller. The post FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator appeared first on MedTech Intelligence.
FDA RECALL UPDATE
ROi CPS, LLC, is recalling newborn kits after receiving an Urgent Field Safety Notice for a kit component from the supplier Mercury Medical. The affected component is the Neo-Tee T-Piece resuscitator, which is being removed by Mercury Medical due to a undersized spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. The issue could reduce positive pressure, affecting the patient’s breathing support.
The use of affected product may cause serious adverse health consequences, including low oxygen levels (desaturation), slow heart rate (bradycardia), lack of oxygen (hypoxia), high carbon dioxide levels (hypercarbia), and death.
There have been no reported injuries or deaths associated with this issue…READ MORE
The post FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator appeared first on MedTech Intelligence.
