Apellis Injection Kit Filter Needles Recalled for Structural Defects
Apellis Pharmaceuticals is recalling 61,943 units of Injection Kit components due to structural variations in the 19-gauge filter needle. No causal relationship has been established between the defect and the rare adverse events observed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm medical device with structural defects in injection filter needles. While no causal relationship has been established between the defect and the rare adverse events observed, injection equipment requires structural integrity for safe patient use.
Plain-English summary
Apellis Pharmaceuticals, Inc. is recalling 61,943 units of its Injection Kit 29g (Ref: IVT-KIT-29G) due to structural defects identified in the 19-gauge filter needle component. The kit is a single-use medical device intended for injecting or withdrawing fluids from areas below the skin surface.
Quality inspections revealed that a small fraction of 19-gauge filter needles in the affected lots exhibited non-preferred structural characteristics. While rare events of retinal vasculitis have been observed, a causal relationship between the structural variations in these needles and the reported adverse events has not been established.
This product was distributed nationwide in the United States across multiple lot numbers: 223186, 230036, 230056, 230236, 230316, 230326, 230336, 230406, 231926, 231946, 231956, and 231986.
Patients and healthcare providers should discontinue use of the product from the affected lots and contact Apellis Pharmaceuticals for guidance on replacements or proper disposal.
The recalled product
- Product
- 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
- Manufacturer
- Apellis Pharmaceuticals, Inc.
- Affected units
- 61,943
Distribution
Distributed nationwide across the United States.
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