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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2021%22
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