Device recall
Z-1897-2009: Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis…
FDA device recall · Class II · Apheresis Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1897-2009 |
|---|---|
| Recall event | 52640 |
| Product | Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange. |
| Product code | FIR |
| Recalling firm | Apheresis Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2010 |
| 510(k) numbers | K961137 |
| FEI number | 1000113717 |
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