Device recall
Z-2653-2023: Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids…
FDA device recall · Class II · Apellis Pharmaceuticals, Inc.
Key facts
| Recall number (Z-number) | Z-2653-2023 |
|---|---|
| Recall event | 92926 |
| Product | Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G |
| Product code | FMI |
| Recalling firm | Apellis Pharmaceuticals, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K222681 |
| FEI number | 3016603289 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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