BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-2653-2023 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2653-2023
    Event ID
    92926
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Apellis Pharmaceuticals, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 11, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    September 29, 2023
    Address
    100 5th Ave Fl 3, N/A, Waltham, MA, 02451-8727, United States

    Description

    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

    Reason

    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

    Code Info

    UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986

    Distribution

    US Nationwide distribution.

    Quantity

    61,943 units