# FDA recall Z-1147-2021

> **Northgate Technologies, Inc.** · Class II · device recall initiated 2021-01-15.

## 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 for recall

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

## Distribution

US Nationwide distribution in the states of FL and OH.

## Key facts

- **Recall number:** Z-1147-2021
- **Recalling firm:** Northgate Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-15
- **Report date:** 2021-03-03
- **Termination date:** 2022-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elgin, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2021

## Citation

> AI Analytics. FDA recall Z-1147-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1147-2021. Source: US FDA. Licensed CC0.

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