Device recall
Z-0331-2013: Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%…
FDA device recall · Class II · Superstat Corp
Key facts
| Recall number (Z-number) | Z-0331-2013 |
|---|---|
| Recall event | 63581 |
| Product | Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous… |
| Product code | LMF |
| Recalling firm | Superstat Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2013 |
| PMA numbers | P810040 |
| FEI number | 3001452136 |
At a glance
- None Linked 510(k)s
- 10–99 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