BEUDAMED
    FDA Recall Terminated

    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

    Recall: Z-0420-2022 · Initiated November 16, 2021

    Recall

    Recall Number
    Z-0420-2022
    Event Number
    89123
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 16, 2021
    Terminated
    June 18, 2024
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

    Reason

    As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.

    Action

    The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices.

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.

    Quantity

    10 units