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ROi CPS LLC recalls Regard, Item Number 830067009, custom cardiovascular procedure kit
Recalled April 14, 2021 · FDA recall Z-1376-2021 · ROi CPS
Hazard
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. · FDA Class II
Units
16 kits
Sold at
US Nationwide distribution in the state of Missouri.
Description
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.
Product
Regard, Item Number 830067009, custom cardiovascular procedure kit
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →