---
title: "regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... — FDA record Z-1047-2025 | Is It on Recall"
description: "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 Resuscit"
url: https://isitonrecall.com/recall/fda-device-z-1047-2025-regard-item-number-830106006-ld01114f-newborn-kit-containing-the-component-neo-tee-resuscitator-conv/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit ... — FDA record Z-1047-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
- **Reason**: 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..
- **Classification**: Class I
- **Recalling firm**: ROi CPS LLC
- **Quantity**: 414 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1047-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1047-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution was made to MO. There was no government/military/foreign distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Missouri](https://isitonrecall.com/state/missouri/)

## Dates in the source

- **Report date**: Feb 12, 2025
- **Recall initiation date**: Dec 26, 2024
- **Center classification date**: Feb 4, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1047-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ROi CPS LLC records](https://isitonrecall.com/brand/roi-cps-llc/)