BEUDAMED
    FDA Enforcement Class II Terminated

    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).

    Recall: Z-0419-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0419-2015
    Event ID
    69584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Acmi, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 21, 2014
    Classification Date
    November 21, 2014
    Termination Date
    March 3, 2017
    Address
    136 Turnpike Road, N/A, Southborough, MA, 01772-2118, United States

    Description

    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).

    Reason

    All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.

    Code Info

    All lots

    Distribution

    Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe

    Quantity

    74,792 units