BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

    Recall: Z-0002-2021 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-0002-2021
    Event ID
    86214
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    August 12, 2020
    Classification Date
    October 1, 2020
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

    Reason

    The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

    Code Info

    Lot Numbers: T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X

    Distribution

    Worldwide distribution - US Nationwide and Global Distribution.

    Quantity

    900,007 total