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FDAJanuary 15, 2021device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

What to do

FDA enforcement status: Terminated

Brands named

northgate technologiesnorthgate

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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