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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