Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
US Nationwide distribution in the states of Ohio and Kansas.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1450-2020