Apellis Pharmaceuticals, Inc.: 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 eithe

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

Details from the source

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 Distribution: US Nationwide distribution. Quantity: 61,943 units Lot/code info: UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986

UPC codes

00860008043672

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.