BEUDAMED
    FDA Enforcement Class II Terminated

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    Recall: Z-2732-2014 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2732-2014
    Event ID
    69132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Apollo Endosurgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 8, 2014
    Initiation Date
    August 15, 2014
    Classification Date
    September 30, 2014
    Termination Date
    February 1, 2016
    Address
    1120 S Capital Of Texas Hwy, Bldg. 1, Ste. 300, West Lake Hills, TX, 78746-6464, United States

    Description

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    Reason

    Product was distributed past its expiration date.

    Code Info

    Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653

    Distribution

    Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.

    Quantity

    10