ROi CPS LLC is recalling 414 units of its regard Newborn Kits (Item Numbers 830106006 and LD01114F) which include the Neo-Tee Resuscitator. The recall was initiated because a spring in the device's inline controller may be out of specification, leading to a loss of positive pressure. This defect prevents the resuscitator from reaching the necessary high and low pressure ranges required to effectively ventilate a newborn. While no injuries have been reported, medical facilities should stop using the affected kits immediately and contact the manufacturer to arrange for a return or replacement.
The mechanical failure of the resuscitator spring means the device cannot maintain the correct air pressure levels needed to help a newborn breathe. This loss of ventilation support during critical labor and delivery procedures could result in serious harm to the patient due to inadequate oxygenation.
Recall #: Z-1047-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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