Apellis Pharmaceuticals, Inc. Recall 92926
Description: 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
Apellis Pharmaceuticals, Inc. Recall 92926 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2653-2023 |
| Event ID | 92926 |
| Event Description | 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 Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 61,943 units |
| Recall Reason | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis |
| Device Classification | 20231011 |
| Device Code Info | UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986 |
| Center Classification Date | 20230929 |
| Recall Initiation Date | 20230822 |
| Recalling Firm | Apellis Pharmaceuticals, Inc. |
| Initial Notification | |
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