BEUDAMED
    FDA Enforcement Class II Terminated

    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

    Recall: Z-2562-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2562-2021
    Event ID
    88485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lymol Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 6, 2021
    Initiation Date
    July 29, 2021
    Classification Date
    September 24, 2021
    Termination Date
    October 4, 2022
    Address
    4 Plympton St, N/A, Woburn, MA, 01801-2917, United States

    Description

    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

    Reason

    Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.

    Code Info

    All distributed lots

    Distribution

    US Nationwide distribution.

    Quantity

    309