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Apellis Pharmaceuticals, Inc. Recall: Apellis Injection Kit 29g Injection Needle -single u

Apellis Pharmaceuticals, Inc. Recall: Apellis Injection Kit 29g Injection Needle -single u is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Apellis Pharmaceuticals, Inc.; Product: Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids f

Recalling firmApellis Pharmaceuticals, Inc.
ProductApellis 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 recall19-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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionUS Nationwide distribution.
Recall initiated20230822
Recall numberZ-2653-2023
Categorydevice
StateMA
CountryUnited States

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