BEUDAMED
    FDA Enforcement Class II Terminated

    K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    Recall: Z-0973-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-0973-2021
    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

    K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    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,09K,95K,96K,97K,98K,99K,9XK,9YK,9ZK

    Distribution

    US Nationwide distribution.

    Quantity

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