Device recall
Z-0318-2016: SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver…
FDA device recall · Class II · TZ Medical Inc.
Key facts
| Recall number (Z-number) | Z-0318-2016 |
|---|---|
| Recall event | 72450 |
| Product | SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic… |
| Product code | FRO |
| Recalling firm | TZ Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| FEI number | 1000127185 |
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