Device recall
Z-0561-2015: ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001…
FDA device recall · Class II · Pfm Medical Inc
Key facts
| Recall number (Z-number) | Z-0561-2015 |
|---|---|
| Recall event | 69666 |
| Product | ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural… |
| Product code | DWM |
| Recalling firm | Pfm Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2015 |
| 510(k) numbers | K093307 |
| FEI number | 3013666218 |
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