Regard, Item Number 830067009, custom cardiovascular procedure kit
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.
US Nationwide distribution in the state of Missouri.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2021