Recall Z-1047-2025— ROi CPS LLC

Name: FDA recall Z-1047-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-26

Class I · Ongoing

Class I FDA medical device recall by ROi CPS LLC, initiated 2024-12-26. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.. Reason: There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient...

Recalling firm: ROi CPS LLC
Classification: Class I
Status: Ongoing
Initiated: 2024-12-26
Firm location: Republic, MO, United States

Product description

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Reason for recall

There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

Data sourced from openFDA. This site is unofficial and independent of the FDA.