BEUDAMED
    FDA Recall Terminated

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    Recall: Z-0803-2020 · Initiated November 27, 2019

    Recall

    Recall Number
    Z-0803-2020
    Event Number
    84367
    Firm
    Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom
    FEI Number
    3006363476
    Product Code
    OGH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 27, 2019
    Posted
    January 13, 2020
    Terminated
    April 27, 2021

    Description

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    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.

    Action

    On 11/27/2019, the firm "Flexicare" sent a "Urgent: medical Device Recall" letter via USPS Priority mail. The letter informed consignees of the recall. In addition to informing consignees of the recall the letter asked consignees to take the following actions: Complete the acknowledgment and receipt form and return this form to Flexicare Inc. On receipt of the form you will be contacted by a representative of Flexicare Inc. to make all necessary further arrangements. The form asked the following of the consignee: -Acknowledge that you have read and understand the recall instructions provided - If you have experienced any adverse events associated with the recalled products. - Check your stock and quarantined inventory - Send completed response forms marked for the attention of Product Manager Anesthesia to email [email protected] or by fax to 949-450-9992 - Identify and notify your customers that were shipped product from the affected lot numbers If you have any questions, please call Product Manager Anesthesia, at 949-450-9999 ext. 102 or email at [email protected].

    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