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
- Serial Numbers
- 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.
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