Regard, Item Number 830067009, custom cardiovascular procedure kit

Reason: 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.

Code information: Lot number: 75818I; Expiration Date: 05/18/2021

Distribution pattern: US Nationwide distribution in the state of Missouri.