Device recall
Z-1697-2015: ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X…
FDA device recall · Class II · Coreva Health Science LLC
Key facts
| Recall number (Z-number) | Z-1697-2015 |
|---|---|
| Recall event | 71279 |
| Product | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room… |
| Product code | FRO |
| Recalling firm | Coreva Health Science LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 26, 2015 |
| 510(k) numbers | K112800 |
| FEI number | 3006324197 |
At a glance
- 1–9 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