Recall Z-1148-2021— Northgate Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2021-01-15, terminated 2022-10-31. It names one FDA 510(k) clearance: K111648. Product: 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..
- Recalling firm
- Northgate Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-15
- Terminated
- 2022-10-31
- Firm location
- Elgin, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.