BEUDAMED
    FDA Recall 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 · Initiated December 19, 2017

    Recall

    Recall Number
    Z-1188-2018
    Event Number
    79471
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    MQF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 19, 2017
    Terminated
    April 9, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    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.

    Action

    Cook Medical sent an Urgent Medical Device Recall dated December 19, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Examine inventory immediately and quarantine affected product(s). 2. Return products to Cook with the Acknowledgement and Receipt Form to receive a product credit. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4.Report adverse events to Cook. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

    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