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Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator with an Undersized Controller Spring
ROi CPS, LLC, is recalling Regard newborn kits after receiving an Urgent Field Safety Notice for a kit component from the supplier Mercury Medical. The affected component is the Neo-Tee T-Piece resuscitator, which is being removed by Mercury Medical due to a spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. The issue could reduce positive pressure, affecting the patient's breathing support.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact ROi CS, LLC.
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