Apellis Pharmaceuticals, Inc. recalls Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts o…

Recall date

August 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2653-2023

FDA classification

Class II

Brand / firm

Apellis Pharmaceuticals, Inc.

Sold / distributed

US Nationwide distribution.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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