FDA Device recall Z-1148-2021
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention medi…
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention medi… by Northgate Technologies, citing an internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1148-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-15 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Northgate Technologies |
| Distribution | US |
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.
Identifiers
| code_info | Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Northgate Technologies
- AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Device · Class II · 2022-06-15 · Northgate Technologies - Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800
FDA Device · Class II · 2021-12-15 · Northgate Technologies - ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumope…
FDA Device · Class II · 2021-03-03 · Northgate Technologies - ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA)
FDA Device · Class II · 2020-05-13 · Northgate Technologies - Probe, 9 FR AUTOLITH
FDA Device · Class II · 2020-05-13 · Northgate Technologies
All Northgate Technologies recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.