Device recall
Z-1624-2020: Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of…
FDA device recall · Class II · Gentell, Inc
Key facts
| Recall number (Z-number) | Z-1624-2020 |
|---|---|
| Recall event | 85034 |
| Product | Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin… |
| 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