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Northgate Technologies, Inc. recalls Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 a
Recalled March 3, 2021 · FDA recall Z-1148-2021 · Northgate Technologies
Hazard
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. · FDA Class II
Units
45 units
Sold at
US Nationwide distribution in the states of FL and OH.
Description
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Product
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.
Manufacturer(s)
Northgate Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →