BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    Recall: Z-1221-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1221-2020
    Event ID
    84585
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microvention, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    November 24, 2019
    Classification Date
    February 13, 2020
    Termination Date
    April 20, 2021
    Address
    35 Enterprise, Aliso Viejo, CA, 92656-2601, United States

    Description

    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    Reason

    The devices may be missing the implant coil.

    Code Info

    Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904155J5; 45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and 45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5.

    Distribution

    The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

    Quantity

    107 units