Device recall
Z-0964-2021: B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used…
FDA device recall · Class II · Aomori Olympus Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0964-2021 |
|---|---|
| Recall event | 87074 |
| Product | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. |
| Product code | FGE |
| Recalling firm | Aomori Olympus Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| 510(k) numbers | K962925 |
| FEI number | 3003995201 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 Products in the same recall event
- 100–999 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