---
title: "regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn... — FDA record Z-0411-2022 | Is It on Recall"
description: "The kit contains a non-sterile needle."
url: https://isitonrecall.com/recall/fda-device-z-0411-2022-regard-clinical-packaging-solutions-item-number-830096005-ob01054e-newborn-kit-containing-2-25ga-x-6/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles. — FDA record Z-0411-2022

Reported terminated

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 Nov 4, 2021. 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 Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
- **Reason**: The kit contains a non-sterile needle.
- **Classification**: Class II
- **Recalling firm**: ROi CPS LLC
- **Quantity**: 40 kits
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0411-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0411-2022%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 #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074. |

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

## Distribution

Distribution was made to Missouri. There was no foreign/military/government 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**: Dec 29, 2021
- **Recall initiation date**: Nov 4, 2021
- **Center classification date**: Dec 22, 2021
- **Termination date**: Aug 7, 2023

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-0411-2022%22)

## Related records

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