BEUDAMED
    FDA Enforcement Class II Terminated

    K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    Recall: Z-0970-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-0970-2021
    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-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - 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, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

    Distribution

    US Nationwide distribution.

    Quantity

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