FDA recall Z-1147-2021

Northgate Technologies, Inc. · Class II · device

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

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

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