BEUDAMED
    FDA Enforcement Class II Ongoing

    Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T

    Recall: Z-1068-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1068-2024
    Event ID
    93752
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    December 19, 2023
    Classification Date
    February 9, 2024
    Address
    7000 Burleson Rd Bldg D, N/A, Austin, TX, 78744-3202, United States

    Description

    Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T

    Reason

    Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

    Code Info

    REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281

    Distribution

    US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE

    Quantity

    3613 Cases