BEUDAMED
    FDA Enforcement Class II Terminated

    Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.

    Recall: Z-0416-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0416-2020
    Event ID
    84108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    October 3, 2019
    Classification Date
    November 16, 2019
    Termination Date
    May 13, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.

    Reason

    Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.

    Code Info

    Lot Number 8361746

    Distribution

    No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.

    Quantity

    400