FDA-Device2023-10-11Class II
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.
Hazard
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
Sold states
US Nationwide distribution.
Affected count
61,943 units
Manufactured in
100 5th Ave Fl 3, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2653-2023Don't want to check this manually?
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