Home / Recalls / Medical Devices
ROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to
Recalled February 12, 2025 · FDA recall Z-1047-2025 · ROi CPS
Hazard
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.. · FDA Class I
Units
414 kits
Sold at
Distribution was made to MO. There was no government/military/foreign distribution.
Description
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..
Product
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →