Device recall
Z-1178-2007: PhaSeal, Protector 14, Item No. P14, US Order No. 21320
FDA device recall · Class II · Carmel Pharma, Inc.
Key facts
| Recall number (Z-number) | Z-1178-2007 |
|---|---|
| Recall event | 38251 |
| Product | PhaSeal, Protector 14, Item No. P14, US Order No. 21320 |
| Product code | FPA |
| Recalling firm | Carmel Pharma, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2013 |
| 510(k) numbers | K001368 |
| FEI number | 3002897967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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