Northgate Technologies, Inc. recalls ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expan…

Recall date

January 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1147-2021

FDA classification

Class II

Brand / firm

Northgate Technologies, Inc.

Sold / distributed

US Nationwide distribution in the states of FL and OH.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).