BEUDAMED
    FDA Enforcement Class II Terminated

    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

    Recall: Z-2767-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2767-2020
    Event ID
    86040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boss Instruments, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 12, 2020
    Initiation Date
    June 26, 2020
    Classification Date
    August 5, 2020
    Termination Date
    July 20, 2021
    Address
    104 Sommerfield Dr, Zion Crossroads, VA, 22942-7009, United States

    Description

    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

    Reason

    The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.

    Code Info

    Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.

    Quantity

    96 devices