Device recall
Z-0175-2007: Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use…
FDA device recall · Class III · Asahi Medical Co., Ltd
Key facts
| Recall number (Z-number) | Z-0175-2007 |
|---|---|
| Recall event | 36430 |
| Product | Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda… |
| Product code | FJI |
| Recalling firm | Asahi Medical Co., Ltd |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 28, 2007 |
| 510(k) numbers | K991512 |
| FEI number | 1000599821 |
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