Reported Mar 3, 2021 · Terminated
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2…
Northgate Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northgate Technologies, Inc. · 1591 Scottsdale Ct · Elgin, IL · 60123-9361
Is this the product you have?
- Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 -
- Product Usagedesigned to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope
- Lot codes and dates
- Lot Codes
93830JEK to 93854JEK93899LEK to 93908LEK93909LEK to 93918LEK
- Lot Codes
- Amount recalled
- 45 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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