BEUDAMED
    FDA Recall Terminated

    BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

    Recall: Z-2566-2021 · Initiated August 16, 2021

    Recall

    Recall Number
    Z-2566-2021
    Event Number
    88562
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    EOX
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    August 16, 2021
    Terminated
    March 11, 2024
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

    Reason

    The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

    Action

    On August __, 2021, the firm distributed Urgent Medical Device Corrective Action letters to customers. The applicable addenda to the reprocessing instructions were attached to the letters. Action steps to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new reprocessing steps. 4. Additional copies of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://www.OlympusConnect.com New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Instruction Manuals], locate the applicable product codes and select the [Download] option. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. For further information, contact the firm's Technical Assistance Center at 1-800-848-9024, option 1.

    Distribution

    Domestic distribution nationwide. Product also distributed globally.

    Quantity

    180