Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
US Nationwide distribution in the states of FL and OH.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2021