BEUDAMED
    FDA Enforcement Class II Terminated

    NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

    Recall: Z-1048-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1048-2021
    Event ID
    87074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aomori Olympus Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    January 4, 2021
    Classification Date
    February 5, 2021
    Termination Date
    March 11, 2024
    Address
    2 Chome 248-1, Okkonoki, Kuroishi, N/A, N/A, Japan

    Description

    NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

    Reason

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

    Code Info

    01K, 02K, 04K, 06K, 0XK, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

    Distribution

    US Nationwide distribution.

    Quantity

    7,400,000 (globally); 260,395 (US)