regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitat...
FDA Recall #Z-1047-2025 — Class I — December 26, 2024
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..
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
414 kits
Distribution
Distribution was made to MO. There was no government/military/foreign distribution.
Code Information
Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated