Device recall
Z-2212-2021: ComfortGel - assists in the prevention and treatment of all pressure injury…
FDA device recall · Class II · Stryker Medical Division of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-2212-2021 |
|---|---|
| Recall event | 88199 |
| Product | ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009 |
| Product code | IKY |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1831750 |
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