Device recall
Z-0739-04: Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S…
FDA device recall · Class II · Asahi Medical Co Ltd
Key facts
| Recall number (Z-number) | Z-0739-04 |
|---|---|
| Recall event | 28341 |
| Product | Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku… |
| Product code | KDI |
| Recalling firm | Asahi Medical Co Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2004 |
| 510(k) numbers | K001250 |
| 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