BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0415-2020 · Initiated October 3, 2019

    Recall

    Recall Number
    Z-0415-2020
    Event Number
    84108
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    MQF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 3, 2019
    Terminated
    May 13, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Guardia Access Nano Embryo Transfer Catheter is use 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.

    Action

    An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers. The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form. Returned Product should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected products where applicable.

    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

    202