Recall Z-1148-2021 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Northgate Technologies, Inc.
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
| 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 | 45 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
| K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR Bracco Diagnostic, Inc., Nov 3, 2011 |