Device recall
Z-0568-2015: ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag…
FDA device recall · Class II · Pfm Medical Inc
Key facts
| Recall number (Z-number) | Z-0568-2015 |
|---|---|
| Recall event | 69666 |
| Product | ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. |
| Product code | FJS |
| Recalling firm | Pfm Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2015 |
| 510(k) numbers | K093796, K113354 |
| 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