BEUDAMED
    FDA Enforcement Class II Ongoing

    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

    Recall: Z-1228-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1228-2023
    Event ID
    91650
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    January 25, 2023
    Classification Date
    March 6, 2023
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

    Reason

    Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

    Code Info

    UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    264 US; 5056 OUS