FDAAugust 22, 2023device

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 recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

apellis pharmaceuticalsapellis

UPCs

00860008043672

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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