Reported Feb 12, 2025 · Ongoing
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to…
ROi CPS LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
- regard Item Number830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery
- Lot codes and dates
Lot number 104006Exp. 9/30/2026UDI (01)10194717119074(17)260930(10)104006and Lot number 103486Exp. 8/31/2026UDI (01)10194717119074(17)260831(10)103486
- Amount recalled
- 414 kits
Where it was sold
Why it was recalled
Stop using this product now
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..
Using this product could cause serious injury, illness or death — stop using it now.
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