Device recall
Z-0350-04: Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
FDA device recall · Class II · Toray Marketing & Sales (America), Inc
Key facts
| Recall number (Z-number) | Z-0350-04 |
|---|---|
| Recall event | 28027 |
| Product | Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a |
| Product code | FJI |
| Recalling firm | Toray Marketing & Sales (America), Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2004 |
| 510(k) numbers | K940910 |
| FEI number | 3001632632 |
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