ROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to…

Recall date

December 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1047-2025

FDA classification

Class I

Brand / firm

ROi CPS LLC

Sold / distributed

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

Why it was recalled

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..

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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