Device recall
Z-1885-2020: ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America…
FDA device recall · Class II · Northgate Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1885-2020 |
|---|---|
| Recall event | 85204 |
| Product | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. |
| Product code | FFK |
| Recalling firm | Northgate Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2021 |
| 510(k) numbers | K914516 |
| FEI number | 1450997 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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