Recall Z-0866-2017— Northgate Technologies, Inc.

Name: FDA recall Z-0866-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-21

Class II · Terminated

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2016-11-21, terminated 2017-11-27. It names one FDA 510(k) clearance: K120151. Product: 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: Device could cause a patient overpressure situation without any visual or auditory indication or warning.

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Terminated: 2017-11-27
Firm location: Elgin, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K120151 — NEBULAE INorthgate Technologies, Inc.·cleared 2012-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.