Reported Dec 28, 2016 · Terminated

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices…

Northgate Technologies, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Northgate Technologies, Inc. · 1591 Scottsdale Ct · Elgin, IL · 60123-9361

Is this the product you have?

  • 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 proceduresGeneral Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Lot codes and dates
  • Serial Numbers
    • #89170HXB
    • #89556DYD
    • #89652FYA
    • #89661FYA
    • #89663FYA
    • #89664FYA
    • #89670FYA
    • #89672FYA
    • #89675FYA
    • #89677FYA
    • #89685FYB
    • #89697FYB
    • #89708GYA
    • #89713GYA
    • #89719GYB
    • #89720GYB
    • #89729GYB
    • #89732GYB
    • #89734GYB
    • #89737GYB
    • #89889IYD
    • #90165AZB
    • #90285BZD
    • #90387DZB
    • #90391DZB
    • #90415DZD
    • #90438DZD
    • #90469EZB
    • #90528EZD
    • #90555FZB
    • #90556FZB
    • #90557FZB
    • #90558FZB
    • #90561FZB
    • #90583GZC
    • #90621GZB
    • #90654HZB
    • #90739IZD
    • #90869KZD
    • #90931LZD
    • #90936LZD
    • #90954LZD
    • #90962LZD
    • #90972LZD
    • #91105CAD
    • #91108CAD
    • #91114CAD
    • #91120CAD
    • #91380FAC
    • #91406FAD
    • #91471GAC
    • #91544IAC
Amount recalled
49 devices

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Northgate Technologies, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 27, 2017 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.