FDA Device recall Z-1147-2021
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumope…
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumope… 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-1147-2021 |
| 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
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
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: 9855JEG to 93879JEG |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1147-2021%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.