---
title: "Regard brand CABG Pack A and B - Spartanburg — FDA record Z-1051-2022 | Is It on Recall"
description: "Kits were packed into shipping boxes incorrectly."
url: https://isitonrecall.com/recall/fda-device-z-1051-2022-regard-brand-cabg-pack-a-and-b-spartanburg/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Regard brand CABG Pack A and B - Spartanburg — FDA record Z-1051-2022

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 Mar 21, 2022. 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 brand CABG Pack A and B - Spartanburg
- **Reason**: Kits were packed into shipping boxes incorrectly.
- **Classification**: Class II
- **Recalling firm**: ROi CPS LLC
- **Quantity**: 85 kits
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1051-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1051-2022%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 | Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156 |

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

## Distribution

Recall impacted one domestic consignee in NC

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

- [North Carolina](https://isitonrecall.com/state/north-carolina/)

## Dates in the source

- **Report date**: May 18, 2022
- **Recall initiation date**: Mar 21, 2022
- **Center classification date**: May 9, 2022
- **Termination date**: Dec 28, 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-1051-2022%22)

## Related records

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