Device recall
Z-0789-05: Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single…
FDA device recall · Class II · Asahi Medical Co Ltd
Key facts
| Recall number (Z-number) | Z-0789-05 |
|---|---|
| Recall event | 31536 |
| Product | Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the… |
| Product code | KDI |
| Recalling firm | Asahi Medical Co Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2006 |
| 510(k) numbers | K013418 |
| FEI number | 3002806407 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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