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
Reported: October 11, 2023 Initiated: August 22, 2023 #Z-2653-2023
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
Details
- Recalling Firm
- Apellis Pharmaceuticals, Inc.
- Units Affected
- 61,943 units
- Distribution
- US Nationwide distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apellis Pharmaceuticals, Inc.. Units affected: 61,943 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2653-2023.
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