ROi CPS recalls Regard cardiovascular procedure kits with potential slits in drapes that could breach sterile barriers during use. Affected kits have lot number 75818I and expire 05/18/2021.
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Take action
Contact the company
📍Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
“Regard Cardiovascular Kit Recall: Slits Risk Sterile Barrier Breach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63163-regard-cardiovascular-kit-recall-slits-risk-sterile-barrier-breach. Based on FDA recall #Z-1376-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1376-2021%22&limit=1).
ROi CPS LLC recalled Regard custom cardiovascular procedure kits due to potential sterile barrier breaches, the FDA said on March 4, 2021. The agency issued a Class II recall for items with slits in drapes that could compromise sterility.
How to tell if you have it
Brand: ROi CPS
Product: Regard, Item Number 830067009
Lot number: 75818I
Expiration Date: 05/18/2021
The hazard
ROi CPS LLC stated that drapes in select Regard customer procedure trays may have slits. These defects could lead to a breach in the sterile barrier between fluid in the basin and slush or warming equipment.
Context
GovInfoNow's records show ROi CPS LLC has issued 27 other recalls since Jan. 3, 2020. Recent brand recalls include a Dec. 26, 2024, newborn kit recall for ineffective ventilation risks and a June 17, 2024, Regard kit recall for pin holes in sterile packaging. Other recent recalls of similar products include Medtronic's April 21, 2026, DLP Retrograde Cannula recall and Bard Peripheral Vascular's Dec. 12, 2025, Broviac Cutdown Trays recall.
How to tell if you have this one
Check for lot number 75818I on the Regard kit packaging. The kit expires May 18, 2021. This recall applies to kits sold before the expiration date.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot number 75818I on the Regard kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Missouri.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1376-2021 (March 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1376-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.