Device recall
Z-2454-2012: Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product…
FDA device recall · Class II · Neomend Inc
Key facts
| Recall number (Z-number) | Z-2454-2012 |
|---|---|
| Recall event | 63156 |
| Product | Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks… |
| Product code | NBE |
| Recalling firm | Neomend Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2012 |
| PMA numbers | P010047 |
| FEI number | 3001237235 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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