FDA Medical Device Recalls (openFDA)
Northgate Technologies, Inc.: 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).
- Recall number
- Z-1147-2021
- Recalling firm
- Northgate Technologies, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2021-01-15
- Posted
- not on file
- Terminated
- 2022-10-31
- Reason
- An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall on 01/15/2021 by email to its direct consignees. The notice requested the consignee cease distribution or use and return the product to NTI. It also directed the consignee to notify their customers if the product was further distributed.
- Quantity
- 25 units
- Distribution
- US Nationwide distribution in the states of FL and OH.
- Lot, serial or model codes
- Lot Codes: 9855JEG to 93879JEG
- 510(k) numbers
- ["K120151"]
- PMA numbers
- not on file
- Product code
- HIF
- Firm FEI
- 1450997
- Firm city
- Elgin
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28