Northgate Technologies, Inc. recalls Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices tha…

Recall date

November 21, 2016

Source

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

Recall number

Z-0866-2017

FDA classification

Class II

Brand / firm

Northgate Technologies, Inc.

Sold / distributed

Worldwide Distribution - US including FL and MA. Internationally to Canada

Why it was recalled

Device could cause a patient overpressure situation without any visual or auditory indication or warning

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

What was recalled

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures