Device recall
Z-1909-2020: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing…
FDA device recall · Class II · Gentell, Inc
Key facts
| Recall number (Z-number) | Z-1909-2020 |
|---|---|
| Recall event | 85373 |
| Product | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and… |
| Product code | FRO |
| Recalling firm | Gentell, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000522686 |
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