BEUDAMED
    FDA Enforcement Class II Terminated

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    Recall: Z-0804-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0804-2020
    Event ID
    84367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flexicare Medical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 22, 2020
    Initiation Date
    November 27, 2019
    Classification Date
    January 13, 2020
    Termination Date
    April 27, 2021
    Address
    Cynon Valley Business Park, Mountain Ash, Rhondda Cynon Taff, N/A, United Kingdom

    Description

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    Reason

    The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.

    Code Info

    Part Number/Lot Number: 040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 I OGH

    Distribution

    US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK

    Quantity

    1,024,890 devices