Class I

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

ROi CPS LLC · December 26, 2024

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..

Distribution

Distribution was made to MO. There was no government/military/foreign distribution.

States Affected

MO

Quantity Affected

414 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1047-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ROi CPS LLC Medical Device Recall: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery. | SafeCheck