FDA Device Recall Z-1047-2025

ROi CPS LLC · Republic, MO

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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.

Quantity: 414 kits

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..

Recall record

Recall number: Z-1047-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distribution was made to MO. There was no government/military/foreign distribution.
Recall initiated: 2024-12-26
Classified by FDA Center: 2025-02-04
FDA published: 2025-02-12
Recalling firm: ROi CPS LLC
Firm location: Republic, MO

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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