Recall Z-1376-2021— ROi CPS LLC

Name: FDA recall Z-1376-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-04

Class II · Ongoing

Class II FDA medical device recall by ROi CPS LLC, initiated 2021-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: ROi CPS LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-03-04
Firm location: Republic, MO, United States

Product description

Regard, Item Number 830067009, custom cardiovascular procedure kit

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.