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.
Reported: March 3, 2021 Initiated: January 15, 2021 #Z-1148-2021
Product Description
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.
Reason for Recall
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Details
- Recalling Firm
- Northgate Technologies, Inc.
- Units Affected
- 45 units
- Distribution
- US Nationwide distribution in the states of FL and OH.
- Location
- Elgin, IL
Frequently Asked Questions
What product 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.. Recalled by Northgate Technologies, Inc.. Units affected: 45 units.
Why was this product recalled? ▼
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1148-2021.
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