Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Regard Recalled by ROi CPS LLC Due to ROi CPS, LLC has become aware, through a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ROi CPS LLC directly.
Affected Products
Regard, Item Number 830067009, custom cardiovascular procedure kit
Quantity: 16 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ROi CPS LLC
ROi CPS LLC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report