Device recall
Z-1148-2021: Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 /…
FDA device recall · Class II · Northgate Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1148-2021 |
|---|---|
| Recall event | 87231 |
| Product | 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 code | FCX |
| Recalling firm | Northgate Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 31, 2022 |
| 510(k) numbers | K111648 |
| FEI number | 1450997 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database