FDA-Device2021-03-03Class II
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
Northgate Technologies, Inc.
Hazard
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Sold states
US Nationwide distribution in the states of FL and OH.
Affected count
25 units
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2021Don't want to check this manually?
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