Northgate Technologies, Inc. Recall 87231
Description: 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.
Northgate Technologies, Inc. Recall 87231 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1148-2021 |
| Event ID | 87231 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL and OH. |
| Quantity | 45 units |
| Recall Reason | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| Device Classification | 20210303 |
| Device Code Info | Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK |
| Center Classification Date | 20210224 |
| Recall Initiation Date | 20210115 |
| Recalling Firm | Northgate Technologies, Inc. |
| Initial Notification | |
| Similar To |