BEUDAMED
    FDA Recall 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 · Initiated July 29, 2021

    Recall

    Recall Number
    Z-2562-2021
    Event Number
    88485
    Firm
    Lymol Medical Corporation
    FEI Number
    1221129
    Product Code
    EOQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 29, 2021
    Terminated
    October 4, 2022
    Address
    4 Plympton St, Woburn, MA, 01801-2917

    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.

    Action

    On August 9, 2021, the firm began notifying all consignees via email that the reprocessing instructions have changed. Included with each notification is a copy of the Urgent Notice, the revised IFU, and a response form. Customers were advised that the sterilization procedures were updated on November 15, 2020. Customers should discard and replace the obsolete procedures with the revised procedures included with the firm's mailing. The revised instructions have been uploaded to the LYMOL website at https://www.lymolmedical.com/instructions.cfm Customers with questions may contact the firm at [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    309