FDAFDA · Food and drugs·Recall number Z-1047-2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Published February 12, 2025 · Recall initiated: December 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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..
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ROi CPS LLC
- Distributor
- Distribution was made to MO. There was no government/military/foreign distribution.
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.