BEUDAMED
    FDA Enforcement Class II Terminated

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    Recall: Z-1188-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1188-2018
    Event ID
    79471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    December 19, 2017
    Classification Date
    March 26, 2018
    Termination Date
    April 9, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    Reason

    Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.

    Code Info

    1. Catalog Number: K-J-SMS-571800, Lot Number: 6802704, Expiration Date: 3/10/2019; 2. Catalog Number: K-JETS-551910-L, Lot Number: NS6360603, Expiration Date: 11/15/2018; 3. Catalog Number: K-JETS-7019-SIVF, Lot Number: 6503675, Expiration Date: 2/2/2019

    Distribution

    Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.

    Quantity

    473