Mercury Medical Recall Neo-Tee T-Piece ResuscitatorsMercury Medical Recall Neo-Tee T-Piece Resuscitators
The company initiated the removal after finding there was a potential for the inline controller to come apart, causing injury.
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Mercury Medical is recalling its Neo-Tee T-Piece resuscitators with manometer and controller with pressure relief valve due to the potential for the inline controller to come apart. The removal has been deemed Class I by 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. The device is indicated for newborns and infants weighing less than 22lbs.
On Sept. 4, Mercury Medical sent all affected customers an Urgent Field Safety Notice after the company found that there was a potential for the inline controller to come apart, causing a loss of positive pressure to the device that would impact effective ventilation. Use of affected product may cause injury from lack of oxygen and death. Currently, there have been no reports of injury or death connected to the issue.
The company is recommending medical facilities and distributors to immediately check inventory for recalled product and stop using it.
Affected lot numbers include:
2417650805
2417750805
2423550832
2417850832
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