Regard CABG Pack A/B Recall: Incorrect Shipping Packaging
Regard CABG Pack A and B products shipped with incorrect packaging may cause improper assembly. Affected units include specific item numbers and lots. Contact manufacturer for details.
Lower-risk recall
Kits were packed into shipping boxes incorrectly.
Contact the company
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. Read more at govinfonow.com/recall/60915-regard-cabg-pack-a-b-recall-incorrect-shipping-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/60915-regard-cabg-pack-a-b-recall-incorrect-shipping-packaging · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1051-2022
Cite this page
“Regard CABG Pack A/B Recall: Incorrect Shipping Packaging.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60915-regard-cabg-pack-a-b-recall-incorrect-shipping-packaging. Based on FDA recall #Z-1051-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1051-2022%22&limit=1).
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- Product
Regard brand CABG Pack A and B - Spartanburg- Category
Medical device
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.
Where it went and when
Where it was distributed
Distributed in North Carolina.
FDA distribution: “Recall impacted one domestic consignee in NC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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.