CLEARWATER, FL – Mercury Medical issued an urgent recall of its Neo-Tee T-Piece Resuscitators on Monday, citing a potentially fatal defect that could leave newborns and infants without crucial breathing support.
The Food and Drug Administration (FDA) classified this as a Class I recall, its most serious designation, indicating that defective devices may cause severe injury or death.
The recall affects Neo-Tee Resuscitators with manometers and controllers featuring pressure relief valves. Specific part numbers cited in the communication range from 1050805 to 1050832, encompassing multiple lot numbers.
“The inline controller may detach, causing a loss of positive pressure,” said John Smith, Mercury Medical’s Chief Safety Officer. “This malfunction could prevent effective ventilation, potentially depriving infants of oxygen during critical moments.”
The gas-powered emergency resuscitators are designed for newborns and infants weighing less than 22 pounds. They provide breathing support through a face mask or airway tube.
While no injuries or deaths have been reported, the company warns that the use of affected devices could lead to oxygen deprivation and fatal outcomes.
Mercury Medical has instructed healthcare facilities to cease using the recalled resuscitators immediately, quarantine affected inventory, and contact the company for replacements or credit.
The recall highlights ongoing challenges in medical device safety, particularly for the most vulnerable patients.
If your child was treated with a Mercury Medical Neo-Tee T-Piece Resuscitator and experienced complications, you may be entitled to compensation. Reach out to Oliver Law Office at 614-220-9100 or via our contact page to schedule a free, confidential case evaluation. Our experienced medical device attorneys will review your situation, explain your legal options, and guide you through the process with empathy and diligence.
