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.
ROi CPS is recalling Regard custom cardiovascular procedure kits that may have slits in the drapes. These slits could allow fluid to leak from the basin into warming equipment, breaking the sterile barrier during medical procedures.
Drapes in the kit may have slits that allow fluid from the basin to leak into warming equipment. This could break the sterile barrier between the fluid and the equipment during medical procedures.
Healthcare professionals using Regard cardiovascular procedure kits with lot number 75818I are most at risk. The recall affects kits sold before May 18, 2021.
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.
Look for lot number 75818I on the Regard kit packaging.
The drapes may have slits that could breach the sterile barrier between fluid in the basin and warming equipment during medical procedures.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
The recall record does not state that the kit is unsafe; it only notes potential slits that could breach the sterile barrier.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1376-2021 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1376-2021 from ROi CPS. 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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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.
