Recall Z-1147-2021 ยท HIF Insufflator, Laparoscopic
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).
| Date | Jan 15, 2021 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120151 | NEBULAE I Northgate Technologies, Inc., Aug 17, 2012 |