Z-2653-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61,943 units
Product 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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986