The US Food and Drug Administration has issued a Class I recall for Mercury Medical’s neonatal Neo-Tee Resuscitators due to a potential fault that could cause the detachment of the inline controller.
The Neo-Tee Resuscitators are intended for use with newborns and infants who weigh less than 22lbs. The gas-powered emergency resuscitator provides emergency breathing support through a face mask or a tube in the patient’s airway. If the inline controller detaches, it can cause a loss of positive pressure that will impact the effective ventilation of the patient and prevent the inline controller from being used.
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Although there have been no reported injuries or deaths, the US regulatory agency has tagged the recall as Class I, as the most serious type. The recall affects four lots of Neo-Tee Resuscitators, with the FDA recommending product removal.
Mercury Medical issued an urgent field safety notice on 4 September advising medical facilities to check their inventory for the affected lots of Neo-Tee T-Piece resuscitators and stop their use and distribution if found. Adding that the affected products should be quarantined, and the company will replace, or credit returned devices.
GlobalData estimates the market for airway management devices to grow from being worth $1.6bn in 2023 to over $2.1bn by 2033. The airway management masks segment is expected to grow from $484m to over $613m during the same period.
Mercury Medical is not the only resuscitator device manufacturer to be hit by a Class I recall issued by the FDA. In March, the FDA issued a Class I recall for Vyaire Medical’s AirLife manual resuscitator devices that covered over six and a half million devices and included nine products from Vyaire’s AirLife range. The recall followed 37 reported incidents of patients not receiving enough ventilation, including two injuries and two deaths.
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By GlobalDataThe Class I recall was a death blow for the company, which declared Chapter 11 bankruptcy four months after the recall. In August, Trudell Medical acquired Vyaire’s respiratory diagnostics (RDx) arm. While US cardiac care firm ZOLL won the bid to acquire Vyaire’s ventilator business.
