Medical device recalls Moderate risk

Northgate Technologies, Inc. recalls Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2…

Recall date
January 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1148-2021
FDA classification
Class II
Brand / firm
Northgate Technologies, Inc.
Sold / distributed
US Nationwide distribution in the states of FL and OH.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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