Regard CABG Pack A/B Recall: Incorrect Shipping Packaging

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Recalling firmROi CPS LLC3000 E Sawyer Rd, N/A · Republic, MO 65738-2758

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Regard CABG Pack A and B products were recalled because they were packed incorrectly in shipping boxes. This could lead to improper assembly and potential safety issues if used without proper packaging.

Why it’s dangerous

The kits were packed incorrectly in shipping boxes, which could lead to improper assembly. This might cause the product to not function correctly when used for cardiac care.

Who’s affected

Owners of Regard CABG Pack A and B products with item number 80:0208017 and lot 91156 are affected. Patients using these products for cardiac care are most at risk.

How to tell if you have this one

Check for item number 800208017 and lot number 91156 on the packaging. The recall specifically applies to Regard CABG Pack A and B products shipped from Spartanburg.

Brand
Regard
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for item number 800208017 and lot number 91156 on the packaging to confirm if your product is affected.

✎ GovInfoNow

Questions people ask

Why was this product recalled?

The kits were packed incorrectly in shipping boxes, which could lead to improper assembly.

What should I do if I have this product?

Check for item number 800208017 and lot number 91156 on the packaging. If affected, contact the manufacturer for details.

Is there a fix for this issue?

The recall record does not specify a remedy or fix for this issue.

Take action

Contact Regard

We’ve drafted a message you can send Regard to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1051-2022 — Regard Regard

Hello,

I own a Regard that is covered by recall Z-1051-2022 from Regard.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1051-2022 (March 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1051-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

ROi CPS LLC recalls Regard brand CABG Pack A and B - Spartanburg

Lower-risk recall