FDA-Device2025-02-12Class I
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
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..
Sold states
Distribution was made to MO. There was no government/military/foreign distribution.
Affected count
414 kits
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1047-2025Don't want to check this manually?
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