FDA-Device2021-04-14Class II
Regard, Item Number 830067009, custom cardiovascular procedure kit
ROi CPS LLC
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.
Sold states
US Nationwide distribution in the state of Missouri.
Affected count
16 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard, Item Number 830067009, custom cardiovascular procedure kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2021Don't want to check this manually?
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