Recall Z-1147-2021— Northgate Technologies, Inc.

Name: FDA recall Z-1147-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Class II · Terminated

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2021-01-15, terminated 2022-10-31. It names one FDA 510(k) clearance: K120151. Product: 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).. Reason: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device..

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Terminated: 2022-10-31
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

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).

Reason for recall

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

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