BEUDAMED
    FDA Recall Open, Classified

    NavaClick Syringe and Needle, Model Number LIN02

    Recall: Z-2535-2024 · Initiated July 12, 2024

    Recall

    Recall Number
    Z-2535-2024
    Event Number
    94963
    Firm
    LINEAGE BIOMEDICAL, INC
    FEI Number
    3030201489
    Product Code
    FMF
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    July 12, 2024
    Posted
    August 8, 2024
    Address
    620 Nw Dixie Hwy, Stuart, FL, 34994-1165

    Description

    NavaClick Syringe and Needle, Model Number LIN02

    Reason

    Incorrect GTIN number on carton.

    Action

    Lineage Biomedical notified consignees via UPS letter on 07/12/2024. The letter instructed consignees to relabel the product with the updated UDI barcode or return inventory on hand for replacement. Additionally, consignees were asked to acknowledge receipt of the notification.

    Distribution

    US Nationwide distribution in the states of Michigan and South Carolina.

    Quantity

    215 cartons (containing 50 pouches each)