Mercury Medical has initiated a recall of 1,300 Neo-Tee T-Piece Resuscitators used to provide emergency breathing support to newborns and infants through a face mask or a tube. The recall was prompted by a manufacturing issue that could potentially lead to a detachment of the inline controller, which is critical for adjusting and monitoring airway pressure during use. This defect could result in a loss of positive pressure, essential for effective ventilation, potentially leading to serious adverse health consequences.
The Food and Drug Administration (FDA) has classified this recall as Class I, indicating that the use of these affected devices may cause serious injuries or death. Despite the severity of the situation, there have been no reported injuries or deaths linked to this problem as of the notice issued by the FDA.
The Neo-Tee T-Piece Resuscitator features an inline controller that allows healthcare professionals to adjust and view the delivered airway pressure. It includes an override button that enables clinicians to achieve higher pressures if necessary. This controller is a significant aspect of the device, central not only to its function but also to Mercury Medical’s marketing as they compete with similar products from other companies like GE Healthcare and Fisher and Paykel Healthcare.
The specific issue leading to the recall involves a missing step in the manufacturing process of the inline controller, identified as “process control” by the FDA. This omission can cause the controller to come apart during use, thereby disrupting the device’s ability to maintain the necessary pressure for ventilating the patient.
In response to this issue, Mercury Medical has contacted its customers, urging them to cease using and distributing the affected devices immediately. The company has instructed those in possession of the recalled resuscitators to quarantine them and reach out to their customer service team. Mercury Medical is offering to facilitate the return of the devices and will provide replacements or credit to the affected parties.
The affected units were distributed across several U.S. states, including Michigan, Florida, South Carolina, Pennsylvania, and Indiana, with a limited distribution in Albania as part of their international market.
Mercury Medical is currently managing the recall and remediation process and coordinating with regulatory authorities to ensure the issue is resolved promptly and safely, minimizing any potential impact on patient health.
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