FDA Recall
Terminated
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.
Recall: Z-1148-2021
·
Initiated January 15, 2021
Recall
- Recall Number
- Z-1148-2021
- Event Number
- 87231
- Firm
- Northgate Technologies, Inc.
- FEI Number
- 1450997
- Product Code
- FCX
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 15, 2021
- Terminated
- October 31, 2022
- Address
- 1591 Scottsdale Ct, Elgin, IL, 60123-9361
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
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Action
The firm initiated the recall on 01/15/2021 by email to its direct consignees. The notice requested the consignee cease distribution or use and return the product to NTI. It also directed the consignee to notify their customers if the product was further distributed.
Distribution
US Nationwide distribution in the states of FL and OH.
Quantity
45 units