BEUDAMED
    FDA Enforcement Class II Terminated

    INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

    Recall: Z-1025-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1025-2021
    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

    INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive 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, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

    Distribution

    US Nationwide distribution.

    Quantity

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