Official recall record

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and

US FDA — Medical Devices · 2024-12-26 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Alert date: 2024-12-26
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 10194717119074
Brand on record: ROi CPS LLC
Product category: Medical Device

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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