Z-0866-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 21, 2016
- Termination Date
- November 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 devices
Product Description
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
Reason for Recall
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Distribution Pattern
Worldwide Distribution - US including FL and MA. Internationally to Canada
Code Information
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