Dive Brief:
- Mercury Medical has recalled 1,300 emergency breathing support devices in response to a problem that can affect ventilation of the patient.
- The Food and Drug Administration, which published an alert about the problem Monday, categorized the action as a Class I recall. Mercury asked customers to stop the use and distribution of the affected devices.
- No reported injuries or deaths have been associated with the issue, but the FDA said affected products could cause serious adverse health consequences.
Dive Insight:
The recall is for Mercury’s Neo-Tee T-Piece Resuscitators. Healthcare professionals use the resuscitator device to provide newborns and infants with emergency breathing support through a face mask or a tube.
The device has an inline controller that allows users to view and adjust the delivered airway pressure. An override button on the controller enables clinicians to reach higher pressures. The controller has been a focus of Mercury’s marketing of a device that competes with products from companies including GE Healthcare and Fisher and Paykel Healthcare. The controller is also the focus of the Class I recall.
Mercury initiated the recall because of “the potential for the inline controller to come apart, causing a loss of positive pressure that will impact effective ventilation of the patient and prevent the inline controller from being used,” according to the FDA’s notice. The controller can come apart because of “a missing manufacturing step,” the FDA said in its database entry. The regulator listed “process control” as the cause of the recall.
The company told anyone with the recalled devices to quarantine the products and contact its customer service team. Mercury will arrange the return of the devices and offer users a replacement or credit.
The FDA said 1,300 affected units are in commerce. Mercury distributed the devices to Michigan, Florida, South Carolina, Pennsylvania and Indiana. International distribution was limited to Albania.
