FDA-Device2021-03-03Class II
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.
Northgate Technologies, Inc.
Hazard
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Sold states
US Nationwide distribution in the states of FL and OH.
Affected count
45 units
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2021Don't want to check this manually?
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